Safeskin Sterile Purple Nitrile Examination Gloves
FDA 510(k) K992062 · Safeskin Corp.
510(k) numberK992062
Submission
- Device name
- Safeskin Sterile Purple Nitrile Examination Gloves
- Applicant
- Safeskin Corp.
San Diego, CA, US - Received
- June 18, 1999
- Decision date
- August 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZA – Polymer Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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 LZA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder…LZA · Special | Top Glove Sdn. Bhd. | 09/09/2026SE |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…LZA · Traditional | Maxter Healthcare, Inc. | 09/09/2026SE |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs…LZA · Special | Gmp Medicare Sdn. Bhd. | 09/08/2026SE |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT…LZA · Traditional | Kossan International Sdn Bhd | 08/18/2026SE |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…LZA · Special | O&M Halyard, Inc. | 07/21/2026SE |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua…LZA · Special | Hartalega NGC Sdn. Bhd. | 07/20/2026SE |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with…LZA · Special | Sw Technologies, Inc. | 06/24/2026SE |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile BlackLZA · Traditional | Kanglongda Vietnam Protection Technology Company… | 06/18/2026SE |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Special | Hartalega NGC Sdn. Bhd. | 06/17/2026SE |
| K260806 | Nitrile Disposable Examination GlovesLZA · Traditional | Vista Industries,, LLC | 06/03/2026SE |
More from Vista Industries,, LLC
| 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 |
| K991951 | Safeskin Synthetic Binyo Powder-Free Polymer Coated Examination Gloves (Green, White)LYZ · Traditional | 07/26/1999SE |
| 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 Sterile Purple Nitrile Examination Gloves cleared by the FDA?
Safeskin Sterile Purple Nitrile Examination Gloves (K992062) received a 510(k) decision of Substantially Equivalent on August 25, 1999, 68 days after the submission was received.
What is the product code of K992062?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.