Safeskin Synthetic Binyo Powder-Free Polymer Coated Examination Gloves (Green, White)
FDA 510(k) K991951 · Safeskin Corp.
510(k) numberK991951
Submission
- Device name
- Safeskin Synthetic Binyo Powder-Free Polymer Coated Examination Gloves (Green, White)
- Applicant
- Safeskin Corp.
San Diego, CA, US - Received
- June 10, 1999
- Decision date
- July 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYZ – Vinyl Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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.
Other 510(k)s with product code LYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)LYZ · Traditional | Basic Medical Technology, Inc. | 04/07/2026SE |
| K252467 | Disposable Vinyl Examination GlovesLYZ · Traditional | Viet Phu Trade and Import Export Co., Ltd. | 10/27/2025SE |
| K252505 | Powder-Free Vinyl Exam Gloves, clearLYZ · Traditional | Basic Medical Technology, Inc. | 08/28/2025SE |
| K241252 | Disposable Vinyl Examination GlovesLYZ · Traditional | Anqing Pukang Medical Technology Co., Ltd. | 05/20/2024SE |
| K230046 | Vinyl examination glovesLYZ · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 03/25/2023SE |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/ClearLYZ · Traditional | Ever Global (Vietnam) Enterprise Corporation | 02/06/2023SE |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleLYZ · Traditional | Ever Global (Vietnam) Enterprise Corporation | 10/19/2022SE |
| K223008 | Disposable Vinyl Examination GlovesLYZ · Traditional | Jiangxi Handspro Products Solutions Co., Ltd. | 10/08/2022SE |
| K222442 | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)LYZ · Traditional | Anhui Bytech Medical Supplies Co., Ltd. | 09/28/2022SE |
| K220055 | Disposable, vinyl examination gloves, YellowLYZ · Traditional | Dezhou Hengchang Medical Technology Co., Ltd. | 08/25/2022SE |
More from Dezhou Hengchang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K993117 | Safeskin Pfe-Xtra Powder-Free Latex Examination Gloves, Protein Content 50 MCG or Less…LYY · Traditional | 03/02/2000SE |
| K994081 | Safeskin Tactylon PF Powder-Free Surgeon's GlovesKGO · Traditional | 01/18/2000SE |
| K992830 | Safeskin Polymer-Coated Nitrile Examination Gloves, Powder-Free Shieldmaster Nitrile GloveLZA · Traditional | 10/27/1999SE |
| K992210 | Shieldmaster Powdered Purple Nitrile Examination GlovesLZA · Traditional | 09/10/1999SE |
| K992162 | Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic…LZC · Traditional | 08/30/1999SE |
| K992062 | Safeskin Sterile Purple Nitrile Examination GlovesLZA · Traditional | 08/25/1999SE |
| K991317 | Powder-Free Latex Surgeon's Glove Safeskin PFS Plus Contains 50MLGM or Less of Total…KGO · Traditional | 05/21/1999SE |
| K970899 | Safeskin Powdered Examination GloveLYY · Traditional | 05/06/1997SE |
| K962139 | SafeskinLZA · Traditional | 12/19/1996SE |
| K953015 | Safeskin SupraKGO · Traditional | 08/28/1995SE |
Questions and answers
When was Safeskin Synthetic Binyo Powder-Free Polymer Coated Examination Gloves (Green, White) cleared by the FDA?
Safeskin Synthetic Binyo Powder-Free Polymer Coated Examination Gloves (Green, White) (K991951) received a 510(k) decision of Substantially Equivalent on July 26, 1999, 46 days after the submission was received.
What is the product code of K991951?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.