Submission Details
| 510(k) Number | K935256 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 1993 |
| Decision Date | March 09, 1994 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
PATIENT EXAMINATION GLOVES
Mar 1994
Decision
128d
Days
Class 1
Risk
About This 510(k) Submission
K935256 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on March 9, 1994, 128 days after receiving the submission on November 1, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
Device Classification
| Product Code | LYY — Latex Patient Examination Glove |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| 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. |
Manufacturer
Similar Devices — LYY Latex Patient Examination Glove
All 1953
K250069 · Comfort Rubber Gloves Industries Sdn. Bhd.
· Apr 2025
K240266 · Sri Trang Gloves (Thailand) Public Company Limited
· Sep 2024
K230573 · Kossan International Sdn Bhd
· Jun 2023
K223298 · Shandong Intco Medical Products Co, Ltd.
· Feb 2023
K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd.
· Nov 2022
K221667 · New Era Medicare Sdn. Bhd.
· Oct 2022
More from Comfort Rubber Gloves...
View all
K250069
· LYY · Apr 2025
K240269
· LZA · Oct 2024
K241528
· LZA · Aug 2024
K192954
· LZA · Jun 2020
K200181
· LZA · Apr 2020