FDA Product Code
FDA Product Code LZC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6250
510(k) Clearances — 79 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | 2026-01-14 | Traditional | PDF ↗ |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025-02-24 | Traditional | PDF ↗ |
| K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-08-30 | Abbreviated | PDF ↗ |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | Better Care Plastic Technology Co., Ltd. | 2022-08-27 | Traditional | PDF ↗ |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | Hl Rubber Industries Sdn Bhd | 2022-05-26 | Traditional | PDF ↗ |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs | Hainan Asther Medical Equipment Co., Ltd. | 2022-05-14 | Traditional | PDF ↗ |
| K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs | Niujian Technology Co., Ltd. | 2022-03-31 | Traditional | PDF ↗ |
| K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs | Changzhou Universal Medical Equipment Co., Ltd. | 2022-03-10 | Traditional | PDF ↗ |
| K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs | Anhui Xinyisheng Medical Technology Co.,Ltd | 2022-01-28 | Traditional | PDF ↗ |
| K213076 | AspenMed+ | Aspen Glove Sdn. Bhd. | 2021-12-20 | Abbreviated | PDF ↗ |
| K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) | Jiangsu Nanfang Medical Co., Ltd. | 2021-12-08 | Traditional | PDF ↗ |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2021-12-06 | Abbreviated | PDF ↗ |
| K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | 0 & M Halyard, Inc. | 2020-10-11 | Abbreviated | PDF ↗ |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | Medline Industires, Inc. | 2020-09-18 | Traditional | PDF ↗ |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corp | 2020-06-04 | Abbreviated | PDF ↗ |
| K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | O&M Halyard, Inc. | 2019-11-08 | Abbreviated | PDF ↗ |
| K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | Encompass Industries Sdn. Bhd. | 2019-10-23 | Traditional | PDF ↗ |
| K182382 | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink | Gmp Medicare Sdn Bhd (F25) | 2019-08-29 | Traditional | PDF ↗ |
| K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | Central Medicare Sdn Bhd | 2019-07-04 | Traditional | PDF ↗ |
| K190159 | Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. | 2019-05-06 | Traditional | PDF ↗ |
| K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | Yty Industry (Manjung) Sdn Bhd | 2019-03-19 | Traditional | PDF ↗ |
| K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | O&M Halyard, Inc. | 2019-02-05 | Abbreviated | PDF ↗ |
| K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018-08-10 | Traditional | PDF ↗ |
| K173766 | PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs | Shen Wei USA, Inc. | 2018-07-08 | Traditional | PDF ↗ |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | Halyard Health | 2018-06-27 | Abbreviated | PDF ↗ |
| K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Comfort Rubber Gloves Industries Sdn. Bhd. | 2018-05-15 | Traditional | PDF ↗ |
| K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Maxter Glove Manufacturing Sdn Bhd | 2018-05-02 | Traditional | PDF ↗ |
| K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Central Medicare Sdn Bhd | 2018-03-05 | Traditional | PDF ↗ |
| K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | 2017-11-28 | Traditional | PDF ↗ |
| K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Central Medicare Sdn Bhd | 2017-11-13 | Traditional | PDF ↗ |
| K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | Careplus (M) Sdn Bhd | 2017-07-24 | Traditional | PDF ↗ |
| K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | Brightway Holdings Sdn. Bhd. | 2017-03-31 | Traditional | PDF ↗ |
| K163017 | Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | Gmp Medicare Sdn. Bhd. | 2017-03-22 | Traditional | PDF ↗ |
| K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017-02-13 | Traditional | PDF ↗ |
| K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves | Halyard Health | 2016-09-06 | Abbreviated | PDF ↗ |
| K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs | Maxter Glove Manufacturing Sdn Bhd | 2016-05-02 | Traditional | PDF ↗ |
| K152222 | NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs | Gmp Medicare Sdn Bhd (F25) | 2016-04-21 | Traditional | PDF ↗ |
| K141982 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Wrp Asia Pacific Sdn. Bhd. | 2015-02-05 | Traditional | PDF ↗ |
| K121811 | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES | Shen Wei (Usa), Inc. | 2012-11-21 | Traditional | PDF ↗ |
| K121926 | BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM | Northstar Healthcare Holdings | 2012-09-20 | Traditional | PDF ↗ |
| K120336 | NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U | Hartalega Sdn Bhd | 2012-06-25 | Traditional | PDF ↗ |
| K102189 | POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM | Latexx Manufacturing Sdn.Bhd. | 2012-03-14 | Traditional | PDF ↗ |
| K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | Perusahaan Getah Asas Sdn. Bhd. | 2010-11-29 | Traditional | PDF ↗ |
| K101822 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Sgmp Co., Ltd. | 2010-11-19 | Traditional | PDF ↗ |
| K101436 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | Shen Wei (Usa), Inc. | 2010-11-17 | Traditional | PDF ↗ |
| K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | Kimberly-Clark | 2010-07-21 | Traditional | PDF ↗ |
| K093500 | POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE | Wear Safe (Malaysia) Sdn. Bhd. | 2010-01-19 | Traditional | PDF ↗ |
| K091643 | POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Gx Corporation Sdn Bhd | 2009-11-02 | Traditional | PDF ↗ |
| K083408 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Wrp Asia Pacific Sdn. Bhd. | 2009-07-31 | Traditional | PDF ↗ |
| K083410 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM | Wrp Asia Pacific Sdn. Bhd. | 2009-07-31 | Traditional | PDF ↗ |
| K083409 | POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL | Wrp Asia Pacific Sdn. Bhd. | 2009-07-29 | Traditional | PDF ↗ |
| K083305 | POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM | Wrp Asia Pacific Sdn. Bhd. | 2009-06-18 | Traditional | PDF ↗ |
| K081971 | BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES | Nitritex (M) Sdn. Bhd. | 2008-12-23 | Traditional | PDF ↗ |
| K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | Kimberly-Clark Corp. | 2008-07-14 | Traditional | PDF ↗ |
| K072197 | POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR | Metacure Surgical Gloves Sdn Bhd | 2008-03-12 | Traditional | PDF ↗ |
| K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED | Kossan Latex Industries(M)Sdn Bhd | 2007-02-27 | Traditional | PDF ↗ |
| K042805 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE | Perusahaan Getah Asas Sdn. Bhd. | 2004-12-16 | Traditional | PDF ↗ |
| K033789 | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING | Cardinalhealth | 2004-05-07 | Traditional | PDF ↗ |
| K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | Cardinalhealth | 2003-11-13 | Traditional | PDF ↗ |
| K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | Perusahaan Getah Asas Sdn. Bhd. | 2003-10-22 | Traditional | PDF ↗ |
| K010211 | STERILE NITRILE POWDER-FREE EXAMINATION GLOVES | Allegiance Healthcare Corp. | 2001-02-15 | Special | PDF ↗ |
| K990677 | ABSOGEL CHEMOTHERAPHY GLOVES | Ampri Rubberware Industries Sdn Bhd | 1999-11-01 | Traditional | PDF ↗ |
| K992162 | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM | Safeskin Corp. | 1999-08-30 | Traditional | PDF ↗ |
| K982832 | PROGUARD, RR-1, RR-2 | Emerson & Co. Srl | 1998-12-23 | Traditional | PDF ↗ |
| K970135 | NITRILE GLOVES | Sage Products, Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K945577 | GUARDIAN II GLOVE | Guardian Group, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K942313 | GUARDIAN GLOVE | Guardian Group, Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K920620 | FLUORO-SHIELD RADIATION REDUCTION GLOVES | Acufex Microsurgical, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K905527 | NEEDLESTICK PROTECTIVE GLOVE | Medev Corp. | 1991-03-22 | Traditional | PDF ↗ |
| K905177 | STAT(TM) GLOVE | Success Builders Intl., Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K903142 | AUKUFLEX(TM) RADIATION RESISTANT GLOVES | Aukland Mfg., Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K896759 | PB PLUS LEAD LATEX GLOVES | Sistem Med-Pro (M) Sdn Bhd | 1990-03-27 | Traditional | PDF ↗ |
| K895195 | CHEMO-TOUCH | Medical Resources, Ltd. | 1990-03-15 | Traditional | PDF ↗ |
| K895781 | ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES | Ansell Intl. | 1990-03-09 | Traditional | PDF ↗ |
| K893093 | FLOUROSHIELD RADIATION REDUCTION GLOVE | Acufex Microsurgical, Inc. | 1990-02-13 | Traditional | PDF ↗ |
| K896076 | L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R) | Advance Medical Designs, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K891315 | ATTENUATING SURGICAL GLOVE | F & L Medical Products Co. | 1989-10-05 | Traditional | PDF ↗ |
| K891968 | ESP RADIATION REDUCTION EXAMINATION GLOVES | Boston Scientific Corp | 1989-05-22 | Traditional | PDF ↗ |
| K882437 | L3 (LEAD LATEX LYSNIG GLOVES) | The Branford Co. | 1989-05-11 | Traditional | PDF ↗ |
Product code LZC · Class I · General Hospital. Data: openFDA.