Nitrile Rubber Examination Gloves (Powered)
FDA 510(k) K932405 · Safeskin Corp.
510(k) numberK932405
Submission
- Device name
- Nitrile Rubber Examination Gloves (Powered)
- Applicant
- Safeskin Corp.
Boca Raton, FL, US - Received
- May 13, 1993
- Decision date
- May 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMC – Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
Other 510(k)s with product code FMC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042618 | Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)FMC · Traditional | La Glove (M) Sdn. Bhd. | 11/26/2004SE |
| K014134 | Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)FMC · Traditional | Supergrade Healthcare Products Sdn. Bhd. | 01/22/2002SE |
| K992337 | Blossom Powder Free Latex Examination Gloves with Protein Content Labeling Claim 50 MCGM…FMC · Traditional | Mexpo Intl., Inc. | 08/17/1999SE |
| K932404 | Nitrile Rubber Powder-Free Examination GloveFMC · Traditional | Safeskin Corp. | 05/18/1994SE |
| K923175 | Surgical Instrument Kit, DisposableFMC · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K920649 | CompasepFMC · Traditional | Wilde-USA, Inc. | 07/23/1992SE |
| K915376 | Glasion VarnishFMC · Traditional | Sci-Pharm Scientific Pharmaceutical, Inc. | 01/22/1992SE |
| K905127 | Latex Glove Application and Removal SystemFMC · Traditional | Success Builders Intl., Inc. | 01/30/1991SE |
| K905109 | Patient Examination Glove/HypoallergenicFMC · Traditional | Tactyl Technologies, Inc. | 11/21/1990SE |
| K903746 | Comfit, Patient Examination GlovesFMC · Traditional | Wembley Rubber Products (M) Sdn Bhd | 09/05/1990SE |
More from Wembley Rubber Products (M) Sdn Bhd
| 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 |
| 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 |
Questions and answers
When was Nitrile Rubber Examination Gloves (Powered) cleared by the FDA?
Nitrile Rubber Examination Gloves (Powered) (K932405) received a 510(k) decision of Substantially Equivalent on May 18, 1994, 370 days after the submission was received.
What is the product code of K932405?
The FDA product code is FMC – Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.