LYY — Latex Patient Examination Glove Class I
Classification Details
- Product Code
- LYY
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250069 | comfort rubber gloves industries sdn. bhd | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Prot | April 29, 2025 |
| K240266 | sri trang gloves (thailand) public company limited | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | September 9, 2024 |
| K230573 | kossan international | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr | June 13, 2023 |
| K223298 | shandong intco medical products co | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | February 22, 2023 |
| K222612 | guangdong kingfa sci. and tech.co | Powder-Free Latex examination gloves | November 25, 2022 |
| K221667 | new era medicare sdn. bhd | Non Sterile Powder Free Latex Examination Glove | October 28, 2022 |
| K222348 | jr engineering and medical technologies (m) sdn. bhd | JR MEDIC | October 27, 2022 |
| K221374 | hebei titans hongsen medical technology co | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | October 26, 2022 |
| K222693 | fitone latex products co., ltd. guangdong | Single-use medical latex examination gloves (LG100) | September 24, 2022 |
| K221648 | iconic medicare | Iconic Latex Glove | August 25, 2022 |
| K211601 | wrp asia pacific sdn. bhd | Powder Free Latex Examination Glove, Non-Sterile | August 22, 2022 |
| K212482 | sri trang gloves (thailand) public company limited | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black | August 9, 2022 |
| K214017 | jiangxi kemei medical apparatus and instruments group co | Examination gloves-Type A(Latex gloves) | July 14, 2022 |
| K221185 | thanh cong pharmaceutical and trading company limited | TC Gloves | June 22, 2022 |
| K212597 | amazing rubber products pvt | Amazing+ Latex Examination Powder Free Gloves | May 28, 2022 |
| K213775 | avecena gloves | Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves | April 24, 2022 |
| K213509 | shandong intco medical products co | Latex Examination Gloves, Powder Free | April 8, 2022 |
| K212309 | sri trang gloves (thailand) public company limited | Non-sterile, Powder-Free Latex Examination Glove | April 8, 2022 |
| K213073 | thai rubber gloves co | Goody Gloves, Wincare, TBG Gloves | December 29, 2021 |
| K212438 | thai rubber industry company limited | Comfortpro | December 7, 2021 |