FDA Product Code
FDA Product Code LZA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6250
510(k) Clearances — 1,181 records · page 2 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231740 | MemorialTM Gloves | Us Glove Supply | 2023-07-04 | Traditional | PDF ↗ |
| K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-06-09 | Traditional | PDF ↗ |
| K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC | 2023-06-06 | Special | PDF ↗ |
| K230633 | APOLLO ADVANTAGE Nitrile Examination Gloves | Dell Corning Corporation | 2023-06-05 | Traditional | PDF ↗ |
| K230542 | Disposable Nitrile Gloves (ABC-DG01) | Huizhou Anboson Technology Co., Ltd. | 2023-05-31 | Traditional | PDF ↗ |
| K230958 | First Glove Blue Nitrile Examination Gloves Powder Free | First Glove Sdn. Bhd. | 2023-05-30 | Abbreviated | PDF ↗ |
| K230601 | Blue Nitrile Examination Gloves Powder Free | Latrile Gloves Private Limited | 2023-05-28 | Abbreviated | PDF ↗ |
| K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | 2023-05-23 | Traditional | PDF ↗ |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | Hartalega NGC Sdn. Bhd. | 2023-05-17 | Traditional | PDF ↗ |
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Careglove Global Sdn. Bhd. | 2023-05-15 | Traditional | PDF ↗ |
| K223280 | Disposible Nitrile Gloves | Holik Asia Group Co.,Ltd | 2023-05-08 | Traditional | PDF ↗ |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-04-27 | Traditional | PDF ↗ |
| K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Professional Latex Sdn Bhd | 2023-03-30 | Traditional | PDF ↗ |
| K220644 | Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs | Yty Industry (Manjung) Sdn Bhd | 2023-03-25 | Traditional | PDF ↗ |
| K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs | Mah Sing Healthcare Sdn. Bhd. | 2023-03-24 | Traditional | PDF ↗ |
| K223895 | Disposable Medical Nitrile Examination Gloves | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2023-03-23 | Traditional | PDF ↗ |
| K222813 | Nitrile Examination Gloves | Ecoglove Medical Manufacturing Company Limited | 2023-03-16 | Traditional | PDF ↗ |
| K223102 | Tegamen Nitrile Examination Gloves | M/S Tegamen Safety Products Private Limited | 2023-03-15 | Traditional | PDF ↗ |
| K223375 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. | Kossan International Sdn Bhd3 | 2023-03-15 | Traditional | PDF ↗ |
| K223859 | Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl | Rhino Health, Inc. | 2023-02-13 | Traditional | PDF ↗ |
| K222129 | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | Top Glove Medical (Thailand) Co., Ltd. | 2023-02-10 | Traditional | PDF ↗ |
| K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | Nephron Pharmaceuticals Corporation | 2023-02-09 | Abbreviated | PDF ↗ |
| K223444 | Powder Free Blue Nitrile Examination Glove | S&S Glove Corporation | 2023-02-06 | Traditional | PDF ↗ |
| K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) | Semperit Investments Asia Pte , Ltd. | 2023-01-27 | Special | PDF ↗ |
| K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mah Sing Healthcare Sdn. Bhd. | 2023-01-26 | Traditional | PDF ↗ |
| K222531 | Synthetic Polymer Glove - Polyethylene (Black) | Ur Industry Sdn Bhd | 2023-01-22 | Traditional | PDF ↗ |
| K223250 | Disposable Nitrile Examination Glove | Yangzhou Saraguard Medical Supplies Co., Ltd. | 2023-01-19 | Traditional | PDF ↗ |
| K223748 | Nitrile Exam Gloves (Chemotherapy Drug Tested) | Us Medical Glove Company, LLC | 2023-01-13 | Traditional | PDF ↗ |
| K223221 | Non-Sterile Powder Free Nitrile Examination Gloves | Dynacare Sdn Bhd | 2023-01-13 | Traditional | PDF ↗ |
| K222181 | Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate | Iconic Medicare Sdn Bhd | 2023-01-11 | Traditional | PDF ↗ |
| K222907 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Rmkh Glove (Cambodia) Co., Ltd. | 2023-01-04 | Traditional | PDF ↗ |
| K222892 | Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | 2022-12-15 | Traditional | PDF ↗ |
| K222527 | Nitrile Patient Examination Glove | Pingan Medical Products Co., Ltd. | 2022-12-14 | Traditional | PDF ↗ |
| K222733 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | Inner Mongolia Boming Medical Supplies Co., Ltd. | 2022-12-11 | Traditional | PDF ↗ |
| K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-12-07 | Abbreviated | PDF ↗ |
| K223281 | Disposable Nitrile Examination Glove | Anhui Kindguard Medical Supplies Technology Co., Ltd. | 2022-12-07 | Traditional | PDF ↗ |
| K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | Zibo Lanhua Medical Packaging Material Co., Ltd. | 2022-12-04 | Traditional | PDF ↗ |
| K223004 | Disposable Nitrile Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | 2022-12-04 | Traditional | PDF ↗ |
| K222713 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | 2022-12-03 | Traditional | PDF ↗ |
| K222715 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | 2022-12-03 | Traditional | PDF ↗ |
| K222720 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | 2022-12-03 | Traditional | PDF ↗ |
| K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | Fitone Latex Products Co., Ltd. Guangdong | 2022-12-01 | Traditional | PDF ↗ |
| K221082 | Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl | Rhino Health, Inc. | 2022-11-30 | Traditional | PDF ↗ |
| K222534 | Nitrile Patient Examination Glove | Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | 2022-11-23 | Traditional | PDF ↗ |
| K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | Sri Trang Gloves (Thailand) Public Company Limited | 2022-11-20 | Abbreviated | PDF ↗ |
| K213981 | Nitrile Examination Gloves | Emerald Glove Manufacturing Sdn Bhd | 2022-11-12 | Traditional | PDF ↗ |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | Hartalega NGC Sdn. Bhd. | 2022-11-11 | Traditional | PDF ↗ |
| K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | Safesource Direct, LLC | 2022-11-07 | Traditional | PDF ↗ |
| K211816 | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Brightway Holdings Sdn. Bhd. | 2022-11-02 | Traditional | PDF ↗ |
| K223320 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2022-11-02 | Traditional | PDF ↗ |
| K220371 | Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Summit Glove, Inc. | 2022-11-02 | Traditional | PDF ↗ |
| K222498 | Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) | Humanwell Healthcare Group Medical Supplies Co., Ltd. | 2022-10-26 | Traditional | PDF ↗ |
| K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | Pt. Sintong Unigolden Glove | 2022-10-26 | Abbreviated | PDF ↗ |
| K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- Black | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-25 | Abbreviated | PDF ↗ |
| K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-21 | Abbreviated | PDF ↗ |
| K222721 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | 2022-10-18 | Traditional | PDF ↗ |
| K222298 | Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Onetexx Sdn Bhd | 2022-10-18 | Traditional | PDF ↗ |
| K222074 | Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves | Zibo Langu New Material Technology Co., Ltd. | 2022-10-17 | Traditional | PDF ↗ |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-10-07 | Special | PDF ↗ |
| K222937 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2022-10-01 | Traditional | PDF ↗ |
| K221378 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile | Tec Gloves Industry (M) Sdn.Bhd. | 2022-09-30 | Traditional | PDF ↗ |
| K222294 | Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Onetexx Sdn Bhd | 2022-09-24 | Traditional | PDF ↗ |
| K212751 | Powder Free Nitrile Examination Glove | Dainam Glove Joint Stock Company | 2022-09-24 | Traditional | PDF ↗ |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-09-24 | Traditional | PDF ↗ |
| K222342 | Betel Gloves Nitrile Examination Glove Powder Free | Betel Care Sdn. Bhd. | 2022-09-24 | Traditional | PDF ↗ |
| K214056 | Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) | Mezorrison Medical Technology (Dongying) Co., Ltd. | 2022-09-20 | Traditional | PDF ↗ |
| K222642 | Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) | Inner Mongolia Cureguard Medical Technology Co., Ltd. | 2022-09-20 | Traditional | PDF ↗ |
| K220697 | Nitrile Patient Examination Gloves, Powder Free | Lalan Rubbers (Pvt), Ltd. | 2022-09-15 | Traditional | PDF ↗ |
| K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) | Careglove Global Sdn. Bhd. | 2022-09-09 | Traditional | PDF ↗ |
| K221164 | Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl | Hong Seng Gloves Sdn Bhd | 2022-08-30 | Traditional | PDF ↗ |
| K221143 | Nitrile Exam Gloves (Blue, Black) | Hebei Astro Medical Supply Co., Ltd. | 2022-08-25 | Traditional | PDF ↗ |
| K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | O&M Halyard, Inc. | 2022-08-16 | Abbreviated | PDF ↗ |
| K213934 | Pro Guard Nitrile Powder Free Examination Glove | Medical Glove Co., Ltd. | 2022-08-06 | Traditional | PDF ↗ |
| K221350 | Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Rubberex Alliance Products Sdn Bhd | 2022-08-05 | Traditional | PDF ↗ |
| K213993 | Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | Careglove Global Sdn. Bhd. | 2022-08-05 | Traditional | PDF ↗ |
| K220237 | Disposable Medical Nitrile Examination Gloves | Fujian Jixiang Medical Technology Co.,Ltd | 2022-08-01 | Traditional | PDF ↗ |
| K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. | 2022-08-01 | Abbreviated | PDF ↗ |
| K221773 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid | Onetexx Sdn Bhd | 2022-07-30 | Traditional | PDF ↗ |
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | 2022-07-27 | Traditional | PDF ↗ |
| K221271 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | Shandong Maida Medical Technology Co., Ltd. | 2022-07-27 | Traditional | PDF ↗ |
| K221877 | Powder-Free Nitrile Examination Glove, Non-Sterile | Goodgloves Industries Sdn Bhd | 2022-07-23 | Traditional | PDF ↗ |
| K220943 | Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim | Eco Medi Glove Sdn. Bhd. | 2022-07-19 | Traditional | PDF ↗ |
| K221229 | Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves | Zibo Blue Sail Health Technology Co., Ltd. | 2022-07-16 | Traditional | PDF ↗ |
| K221108 | Nitrile Medical Examination Gloves | Anhui Fulewei Electronic Technology Co.,Ltd | 2022-07-12 | Traditional | PDF ↗ |
| K221454 | Disposable Medical Nitrile Examination Gloves - Non Sterile | Guangzhou Kangling Biotechnology Co., Ltd. | 2022-07-12 | Traditional | PDF ↗ |
| K213574 | Nitrile Vinyl Blend Powder Free Examination Gloves (Black) | Grand Work Plastic Products Co., Ltd. | 2022-07-12 | Traditional | PDF ↗ |
| K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | American Nitrile Operations, LLC | 2022-07-08 | Abbreviated | PDF ↗ |
| K220284 | Powder Free Nitrile Examination Gloves (Blue) | Kgm Gloves Sdn. Bhd. | 2022-07-08 | Traditional | PDF ↗ |
| K220834 | Powder Free Nitrile Examination Glove | Daxwell, LLC | 2022-06-29 | Traditional | PDF ↗ |
| K221192 | Disposable Nitrile Powder-Free Examination Gloves | Shandong Maida Medical Technology Co., Ltd. | 2022-06-22 | Traditional | PDF ↗ |
| K213739 | Nitrile Examination Gloves | Hangzhou Runheng Medical Co., Ltd. | 2022-06-22 | Traditional | PDF ↗ |
| K220431 | Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile | One Glove Industrial Sdn Bhd | 2022-06-17 | Traditional | PDF ↗ |
| K221186 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | 2022-06-16 | Traditional | PDF ↗ |
| K221226 | 1st Glove Blue Nitrile Examination Gloves Powder Free | Koove Iot Pvt. , Ltd. | 2022-06-16 | Abbreviated | PDF ↗ |
| K220693 | Zoupure Nitrile Powder Free Examination glove | Thai Rayong Product Glove Zoupure Co., Ltd. | 2022-06-07 | Traditional | PDF ↗ |
| K213448 | Powder Free Nitrile Gloves | St Future International Limited | 2022-06-06 | Traditional | PDF ↗ |
| K220672 | Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim | Riverstone Resources Sdn Bhd | 2022-06-03 | Traditional | PDF ↗ |
| K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | 2022-06-02 | Special | PDF ↗ |
| K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | 2022-06-02 | Special | PDF ↗ |
| K220488 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. | 2022-06-01 | Traditional | PDF ↗ |
Product code LZA · Class I · General Hospital. Data: openFDA.