LYY · Latex Patient Examination Glove
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | LYY |
|---|---|
| Device Name | Latex Patient Examination Glove |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 1954)
Showing 20 most recent of 1954 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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. | Apr 29, 2025 | SESE |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | Sep 9, 2024 | SESE |
| 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 | Jun 13, 2023 | SESE |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | Feb 22, 2023 | SESE |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Nov 25, 2022 | SESE |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | Oct 28, 2022 | SESE |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | Oct 27, 2022 | SESE |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | Oct 26, 2022 | SESE |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | Sep 24, 2022 | SESE |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | Aug 25, 2022 | SESE |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | Aug 22, 2022 | SESE |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Sri Trang Gloves (Thailand) Public Company Limited | Aug 9, 2022 | SESE |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | Jul 14, 2022 | SESE |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | Jun 22, 2022 | SESE |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | May 28, 2022 | SESE |
| K213775 | Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | Apr 24, 2022 | SESE |
| K213509 | Latex Examination Gloves, Powder Free | Shandong Intco Medical Products Co, Ltd. | Apr 8, 2022 | SESE |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | Sri Trang Gloves (Thailand) Public Company Limited | Apr 8, 2022 | SESE |
| K213073 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | Dec 29, 2021 | SESE |
| K212438 | Comfortpro | Thai Rubber Industry Company Limited | Dec 7, 2021 | SESE |
Top Applicants
- Wembley Rubber Products (M) Sdn Bhd — 37 clearances
- Sgmp Co., Ltd. — 25 clearances
- Hartalega Sdn Bhd — 19 clearances
- Siam Sempermed Corp., Ltd. — 19 clearances
- Perusahaan Getah Asas Sdn. Bhd. — 16 clearances
