FDA Product Code
FDA Product Code LYY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6250
510(k) Clearances — 1,954 records · page 1 of 20
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 | Traditional | PDF ↗ |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | 2024-09-09 | Abbreviated | PDF ↗ |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd | 2023-06-13 | Traditional | PDF ↗ |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | 2023-02-22 | Traditional | PDF ↗ |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-11-25 | Traditional | PDF ↗ |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | 2022-10-28 | Traditional | PDF ↗ |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-27 | Abbreviated | PDF ↗ |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022-10-26 | Traditional | PDF ↗ |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022-09-24 | Traditional | PDF ↗ |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | 2022-08-25 | Traditional | PDF ↗ |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | 2022-08-22 | Traditional | PDF ↗ |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Sri Trang Gloves (Thailand) Public Company Limited | 2022-08-09 | Abbreviated | PDF ↗ |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022-07-14 | Traditional | PDF ↗ |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | 2022-06-22 | Traditional | PDF ↗ |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | 2022-05-28 | Abbreviated | PDF ↗ |
| K213775 | Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | 2022-04-24 | Traditional | PDF ↗ |
| K213509 | Latex Examination Gloves, Powder Free | Shandong Intco Medical Products Co, Ltd. | 2022-04-08 | Traditional | PDF ↗ |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | Sri Trang Gloves (Thailand) Public Company Limited | 2022-04-08 | Abbreviated | PDF ↗ |
| K213073 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | 2021-12-29 | Abbreviated | PDF ↗ |
| K212438 | Comfortpro | Thai Rubber Industry Company Limited | 2021-12-07 | Abbreviated | PDF ↗ |
| K203074 | Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) | Pt. Universal Gloves | 2021-11-19 | Traditional | PDF ↗ |
| K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | 2021-11-05 | Traditional | PDF ↗ |
| K211477 | Latex Examination Powder Free Gloves | Aspen Glove Sdn. Bhd. | 2021-09-20 | Abbreviated | PDF ↗ |
| K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | Careplus (M) Sdn Bhd | 2021-08-20 | Traditional | PDF ↗ |
| K211620 | Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) | Shen Wei USA, Inc. | 2021-08-19 | Traditional | PDF ↗ |
| K201576 | Disposable Latex Powder Free Examination Gloves (Non-sterile) | Pt. Universal Gloves | 2021-05-19 | Traditional | PDF ↗ |
| K202377 | Palm Care Latex Examination Powder Free Gloves | Hi-Care Thai Gloves Co. , Ltd. | 2020-12-01 | Abbreviated | PDF ↗ |
| K192329 | Blue Latex Examination Powder Free Gloves | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2019-11-25 | Abbreviated | PDF ↗ |
| K173053 | POWDER FREE LATEX EXAMINATION GLOVE | Professional Latex Sdn Bhd | 2018-06-06 | Traditional | PDF ↗ |
| K171367 | SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) | Sanrea Healthcare Products Pvt, Ltd. | 2018-01-26 | Traditional | PDF ↗ |
| K170094 | POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED | Vietglove Corporation | 2017-06-23 | Traditional | PDF ↗ |
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein | Terang Nusa Sdn Bhd | 2017-05-24 | Special | PDF ↗ |
| K161833 | LATEX EXAMINATION GLOVE POWDER FREE | Careglove Global Sdn. Bhd. | 2017-05-23 | Traditional | PDF ↗ |
| K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | Ug Global Resources Sdn. Bhd. | 2017-05-11 | Traditional | PDF ↗ |
| K162175 | Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less | Vietglove Corporation | 2016-11-21 | Traditional | PDF ↗ |
| K153744 | A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) | A1 Glove Sdn Bhd | 2016-08-04 | Traditional | PDF ↗ |
| K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega Sdn Bhd | 2016-08-04 | Traditional | PDF ↗ |
| K152593 | LATEX EXAMINATION GLOVE POWDER FREE | Careplus (M) Sdn Bhd | 2016-02-25 | Traditional | PDF ↗ |
| K150612 | Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) | Anhui Anyu Latex Products Co., Ltd. | 2015-11-16 | Traditional | PDF ↗ |
| K141042 | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES | Mercator Medical (Thailand), Ltd. | 2015-03-19 | Traditional | PDF ↗ |
| K143419 | Patient Examination Gloves | Hartalega NGC Sdn. Bhd. | 2015-03-06 | Traditional | PDF ↗ |
| K142270 | LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE | Hartalega Sdb. Bhd. | 2014-11-25 | Traditional | PDF ↗ |
| K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M | Hartalega Sdn Bhd | 2014-05-28 | Traditional | PDF ↗ |
| K123537 | POWDER FREE LATEX EXAMINATION GLOVES | Qube Medical Product Sdn Bhd | 2014-02-12 | Traditional | PDF ↗ |
| K121844 | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | Worldmed Manufacturing Sdn. Bhd. | 2013-09-06 | Traditional | PDF ↗ |
| K130667 | POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL | Preventive Care, Inc. | 2013-07-24 | Traditional | PDF ↗ |
| K123368 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT | Hartalega Sdn Bhd | 2013-05-07 | Traditional | PDF ↗ |
| K123819 | MULTIPLE NAME | Top Calibre Sdn Bhd | 2013-03-05 | Traditional | PDF ↗ |
| K123757 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR | Assurguard Sdn. Bhd. | 2013-02-01 | Traditional | PDF ↗ |
| K122788 | TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O | Northstar Healthcare Holdings | 2013-01-17 | Traditional | PDF ↗ |
| K123026 | TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO | Northstar Healthcare Holdings | 2012-11-16 | Traditional | PDF ↗ |
| K121594 | COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) | Tekmedic (M) Sdn Bhd | 2012-10-25 | Traditional | PDF ↗ |
| K121591 | FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) | Tekmedic (M) Sdn Bhd | 2012-10-11 | Traditional | PDF ↗ |
| K112693 | NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES | Sgmp Co., Ltd. | 2012-09-12 | Traditional | PDF ↗ |
| K113685 | POWDER FREE LATEX EXAMINATION GLOVES | Khai Hoan Joint Stock Company | 2012-08-10 | Traditional | PDF ↗ |
| K120963 | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | Medtexx Manufacturing Sdn. Bhd. | 2012-06-29 | Traditional | PDF ↗ |
| K111604 | LANO-E | Ug Global Resources Sdn. Bhd. | 2012-06-08 | Traditional | PDF ↗ |
| K120692 | LATEX EXAMINATION GLOVES (POWDER FREE) | Top Calibre Sdn Bhd | 2012-05-14 | Traditional | PDF ↗ |
| K120693 | LATEX EXAMINATION GLOVES (POWDERED) | Top Calibre Sdn Bhd | 2012-05-08 | Traditional | PDF ↗ |
| K112005 | NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Ug Healthcare (Usa), Inc. | 2012-03-21 | Traditional | PDF ↗ |
| K112612 | POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM | Top Calibre Sdn Bhd | 2012-01-18 | Traditional | PDF ↗ |
| K112988 | POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE | Northstar Healthcare Holdings Limited | 2011-11-09 | Traditional | PDF ↗ |
| K111923 | SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | Pt. Intan Hevea Industry | 2011-11-04 | Abbreviated | PDF ↗ |
| K110250 | MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES | Total Gloves Sdn Bhd | 2011-10-14 | Traditional | PDF ↗ |
| K111158 | LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Innovative Gloves Co;, Ltd. | 2011-08-10 | Traditional | PDF ↗ |
| K111133 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) | Ssc Surat Thani | 2011-06-24 | Abbreviated | PDF ↗ |
| K100895 | PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) | Dipped Products Limited | 2011-05-27 | Traditional | PDF ↗ |
| K102902 | RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR | Rubbercare Protection Products Sdn Bhd | 2011-04-22 | Traditional | PDF ↗ |
| K103602 | EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM | Medline Industries, Inc. | 2011-04-21 | Traditional | PDF ↗ |
| K103650 | NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM | Oon Corp. Resources | 2011-03-23 | Traditional | PDF ↗ |
| K102840 | PATIENT EXAMINATION GLOES | Thai Hua Holding Co., Ltd. | 2011-02-18 | Traditional | PDF ↗ |
| K102838 | PATIENT EXAMINATION GLOVES | Thai Hua Holding Co., Ltd. | 2011-02-03 | Traditional | PDF ↗ |
| K101105 | POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 | Best Putra Gloves Sdn Bhd | 2010-11-10 | Traditional | PDF ↗ |
| K101106 | POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 | Best Putra Gloves Sdn Bhd | 2010-11-10 | Traditional | PDF ↗ |
| K101917 | COMFORT RUBBER GLOVES IND.SDN.BHD. | Comfort Rubber Gloves Industries Sdn. Bhd. | 2010-10-29 | Traditional | PDF ↗ |
| K101828 | POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Gx Corporation Sdn Bhd | 2010-10-04 | Traditional | PDF ↗ |
| K101799 | POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE | Wear Safe (Malaysia) Sdn. Bhd. | 2010-09-03 | Traditional | PDF ↗ |
| K101645 | NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF | Latexx Manufacturing Sdn.Bhd. | 2010-08-26 | Traditional | PDF ↗ |
| K100611 | RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) | Riverstone Resources Sdn Bhd | 2010-07-16 | Traditional | PDF ↗ |
| K100907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL | Siam Sempermed Corp., Ltd. | 2010-07-09 | Abbreviated | PDF ↗ |
| K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | Tekmedic (M) Sdn Bhd | 2010-06-25 | Traditional | PDF ↗ |
| K093193 | LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) | La Glove (M) Sdn. Bhd. | 2010-06-08 | Traditional | PDF ↗ |
| K100211 | PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA | Shen Wei (Usa), Inc. | 2010-05-11 | Traditional | PDF ↗ |
| K092681 | POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | Khai Hoan Joint Stock Company | 2010-02-23 | Traditional | PDF ↗ |
| K093496 | NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT | Oon Corp. Resources | 2010-02-03 | Traditional | PDF ↗ |
| K093375 | KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) | Koon Seng Sdn Bhd | 2009-12-02 | Traditional | PDF ↗ |
| K092499 | LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) | La Glove (M) Sdn. Bhd. | 2009-11-20 | Traditional | PDF ↗ |
| K092492 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O | Wear Safe (Malaysia) Sdn. Bhd. | 2009-10-21 | Traditional | PDF ↗ |
| K083571 | ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR | Purna Bina Sdn Bhd | 2009-08-13 | Traditional | PDF ↗ |
| K083761 | ALATECH POWDER FREE LATEX EXAMINATION GLOVE | Alatech Healthcare, LLC | 2009-07-22 | Abbreviated | PDF ↗ |
| K090327 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE | Wear Safe (Malaysia) Sdn. Bhd. | 2009-04-03 | Traditional | PDF ↗ |
| K083337 | NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES | Terang Nusa Sdn Bhd | 2009-01-27 | Special | PDF ↗ |
| K081910 | NON-STERILE, POWDERED LATEX EXAMINATION GLOVE | Siam Sempermed Corp., Ltd. | 2008-09-17 | Abbreviated | PDF ↗ |
| K081907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) | Siam Sempermed Corp., Ltd. | 2008-09-03 | Abbreviated | PDF ↗ |
| K081488 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | Pt. Maja Agung Latexindo | 2008-08-28 | Traditional | PDF ↗ |
| K081464 | STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES | Cardinalhealth | 2008-08-28 | Traditional | PDF ↗ |
| K080606 | ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE | Alatech Healthcare, LLC | 2008-08-07 | Abbreviated | PDF ↗ |
| K081040 | POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE | Pt.Shamrock Manufacturing Corp. | 2008-05-20 | Traditional | PDF ↗ |
| K072300 | POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM | Perusahaan Pelindung Getah (M) Sdn Bhd | 2008-05-16 | Traditional | PDF ↗ |
| K072614 | MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE | Matang Mfg. Sdn. Bhd. | 2008-04-15 | Traditional | PDF ↗ |
Product code LYY · Class I · General Hospital. Data: openFDA.