Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LYY — Predicate Candidate Screening
1,954 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
210 days90th percentile
1,954clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 | 109 | 0 |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural | Sri Trang Gloves (Thailand) Public Company Limited | 2024-09-09 | 222 | 0 |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, | Kossan International Sdn Bhd | 2023-06-13 | 104 | 0 |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra | Shandong Intco Medical Products Co, Ltd. | 2023-02-22 | 118 | 0 |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-11-25 | 87 | 0 |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | 2022-10-28 | 142 | 0 |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-27 | 85 | 0 |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022-10-26 | 167 | 0 |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022-09-24 | 18 | 0 |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | 2022-08-25 | 79 | 0 |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | 2022-08-22 | 455 | 0 |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, | Sri Trang Gloves (Thailand) Public Company Limited | 2022-08-09 | 365 | 0 |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022-07-14 | 204 | 0 |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | 2022-06-22 | 58 | 0 |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | 2022-05-28 | 285 | 0 |
| K213775 | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | 2022-04-24 | 143 | 0 |
| K213509 | Latex Examination Gloves, Powder Free | Shandong Intco Medical Products Co, Ltd. | 2022-04-08 | 157 | 0 |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | Sri Trang Gloves (Thailand) Public Company Limited | 2022-04-08 | 259 | 0 |
| K213073 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | 2021-12-29 | 97 | 0 |
| K212438 | Comfortpro | Thai Rubber Industry Company Limited | 2021-12-07 | 125 | 0 |
| K203074 | Disposable Latex Examination Gloves (Non-Sterile), Disposabl | Pt. Universal Gloves | 2021-11-19 | 406 | 0 |
| K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | 2021-11-05 | 280 | 0 |
| K211477 | Latex Examination Powder Free Gloves | Aspen Glove Sdn. Bhd. | 2021-09-20 | 131 | 0 |
| K203705 | Latex Examination Glove, Powder free with Protein Content La | Careplus (M) Sdn Bhd | 2021-08-20 | 245 | 0 |
| K211620 | Biodegradable Powder Free Latex Examination Gloves Natural, | Shen Wei USA, Inc. | 2021-08-19 | 85 | 0 |
| K201576 | Disposable Latex Powder Free Examination Gloves (Non-sterile | Pt. Universal Gloves | 2021-05-19 | 342 | 0 |
| K202377 | Palm Care Latex Examination Powder Free Gloves | Hi-Care Thai Gloves Co. , Ltd. | 2020-12-01 | 103 | 0 |
| K192329 | Blue Latex Examination Powder Free Gloves | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2019-11-25 | 90 | 0 |
| K173053 | POWDER FREE LATEX EXAMINATION GLOVE | Professional Latex Sdn Bhd | 2018-06-06 | 251 | 0 |
| K171367 | SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as G | Sanrea Healthcare Products Pvt, Ltd. | 2018-01-26 | 262 | 0 |
| K170094 | POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED | Vietglove Corporation | 2017-06-23 | 163 | 0 |
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Co | Terang Nusa Sdn Bhd | 2017-05-24 | 70 | 0 |
| K161833 | LATEX EXAMINATION GLOVE POWDER FREE | Careglove Global Sdn. Bhd. | 2017-05-23 | 322 | 0 |
| K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | Ug Global Resources Sdn. Bhd. | 2017-05-11 | 297 | 0 |
| K162175 | Powder Free Latex Examination Glove with Protein Labeling Cl | Vietglove Corporation | 2016-11-21 | 110 | 0 |
| K161006 | Latex Powder Free Polymer Coated Examination Glove with Prot | Hartalega Sdn Bhd | 2016-08-04 | 115 | 0 |
| K153744 | A1 Glove Powder Free Latex Patient Examination Gloves with P | A1 Glove Sdn Bhd | 2016-08-04 | 220 | 0 |
| K152593 | LATEX EXAMINATION GLOVE POWDER FREE | Careplus (M) Sdn Bhd | 2016-02-25 | 168 | 0 |
| K150612 | Annuy Latex Patient Examination Glove (powdered and powder-f | Anhui Anyu Latex Products Co., Ltd. | 2015-11-16 | 251 | 0 |
| K141042 | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES | Mercator Medical (Thailand), Ltd. | 2015-03-19 | 330 | 0 |
| K143419 | Patient Examination Gloves | Hartalega NGC Sdn. Bhd. | 2015-03-06 | 98 | 0 |
| K142270 | LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAI | Hartalega Sdb. Bhd. | 2014-11-25 | 102 | 0 |
| K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL | Hartalega Sdn Bhd | 2014-05-28 | 156 | 0 |
| K123537 | POWDER FREE LATEX EXAMINATION GLOVES | Qube Medical Product Sdn Bhd | 2014-02-12 | 453 | 0 |
| K121844 | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | Worldmed Manufacturing Sdn. Bhd. | 2013-09-06 | 438 | 0 |
| K130667 | POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL | Preventive Care, Inc. | 2013-07-24 | 134 | 0 |
| K123368 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL | Hartalega Sdn Bhd | 2013-05-07 | 187 | 0 |
| K123819 | MULTIPLE NAME | Top Calibre Sdn Bhd | 2013-03-05 | 83 | 0 |
| K123757 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN C | Assurguard Sdn. Bhd. | 2013-02-01 | 56 | 0 |
| K122788 | TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE | Northstar Healthcare Holdings | 2013-01-17 | 128 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda