Product code LYYClass 1
Latex Patient Examination Glove 510(k) Clearances
Product code LYY is the FDA classification for Latex Patient Examination Glove, a Class 1 device regulated under 21 CFR 880.6250, reviewed by the FDA General Hospital panel. FDA has cleared 1,954 510(k) submissions under this product code.
A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Devices under product code LYYshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.
- Cleared devices
- 1,954
- Device class
- Class 1
- Regulation
- 880.6250
- Latest clearance
Cleared devices under product code LYY
Showing the 50 most recent of 1,954 cleared devices. Clearances from 2013-01-17 to 2025-04-29.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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. | |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | |
| 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 | |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Sri Trang Gloves (Thailand) Public Company Limited | |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | |
| K213775 | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | Sri Trang Gloves (Thailand) Public Company Limited | |
| K213509 | Latex Examination Gloves, Powder Free | Shandong Intco Medical Products Co, Ltd. | |
| K213073 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | |
| K212438 | Comfortpro | Thai Rubber Industry Company Limited | |
| K203074 | Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) | Pt. Universal Gloves | |
| K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | |
| K211477 | Latex Examination Powder Free Gloves | Aspen Glove Sdn. Bhd. | |
| K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | Careplus (M) Sdn Bhd | |
| 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. | |
| K201576 | Disposable Latex Powder Free Examination Gloves (Non-sterile) | Pt. Universal Gloves | |
| K202377 | Palm Care Latex Examination Powder Free Gloves | Hi-Care Thai Gloves Co. , Ltd. | |
| K192329 | Blue Latex Examination Powder Free Gloves | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | |
| K173053 | POWDER FREE LATEX EXAMINATION GLOVE | Professional Latex Sdn Bhd | |
| K171367 | SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) | Sanrea Healthcare Products Pvt, Ltd. | |
| K170094 | POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED | Vietglove Corporation | |
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein | Terang Nusa Sdn Bhd | |
| K161833 | LATEX EXAMINATION GLOVE POWDER FREE | Careglove Global Sdn. Bhd. | |
| K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | Ug Global Resources Sdn. Bhd. | |
| K162175 | Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less | Vietglove Corporation | |
| 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 | |
| K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega Sdn Bhd | |
| K152593 | LATEX EXAMINATION GLOVE POWDER FREE | Careplus (M) Sdn Bhd | |
| 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. | |
| K141042 | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES | Mercator Medical (Thailand), Ltd. | |
| K143419 | Patient Examination Gloves | Hartalega NGC Sdn. Bhd. | |
| K142270 | LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE | Hartalega Sdb. Bhd. | |
| K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M | Hartalega Sdn Bhd | |
| K123537 | POWDER FREE LATEX EXAMINATION GLOVES | Qube Medical Product Sdn Bhd | |
| K121844 | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | Worldmed Manufacturing Sdn. Bhd. | |
| K130667 | POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL | Preventive Care, Inc. | |
| K123368 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT | Hartalega Sdn Bhd | |
| K123819 | MULTIPLE NAME | Top Calibre Sdn Bhd | |
| K123757 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR | Assurguard Sdn. Bhd. | |
| K122788 | TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O | Northstar Healthcare Holdings |
Filing a 510(k) for a Latex Patient Examination Glove of this type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.