Comfit, Patient Examination Gloves
FDA 510(k) K903746 · Wembley Rubber Products (M) Sdn Bhd
510(k) numberK903746
Submission
- Device name
- Comfit, Patient Examination Gloves
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
Kuala Lumpur, Malaysia, MY - Received
- August 13, 1990
- Decision date
- September 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K932405 | Nitrile Rubber Examination Gloves (Powered)FMC · Traditional | Safeskin Corp. | 05/18/1994SE |
| 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 |
More from Tactyl Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982600 | Profeel Synthetic Copolymer Surgical Gloves (Powdered)KGO · Traditional | 03/12/1999SE |
| K972616 | Oncology Plus Powder Free Latex Examination Gloves (Protein Content Labeling)LYY · Traditional | 01/27/1999SE |
| K972615 | Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling)LYY · Traditional | 01/26/1999SE |
| K972621 | Profeel Powder Free Surgical Gloves (Protein Content Labeling)KGO · Traditional | 10/24/1997SE |
| K953213 | Comfit (Powder Free Examination Gloves (Hypoallergenic, Low Protein, Beaded)LYY · Traditional | 10/11/1996SE |
| K962189 | Comfit Powder Free Green Examination Gloves (Hypoallergenic, Low Protein)LYY · Traditional | 07/26/1996SE |
| K962188 | Comfit Powder Free Blue Examination Gloves (Hypoallergenic, Low Protein)LYY · Traditional | 07/26/1996SE |
| K953590 | ComfitLYY · Traditional | 06/27/1996SE |
| K960178 | Comfit Brown, Beaded Surgeon's Gloves (Powdered, Hypoallergenic)KGO · Traditional | 05/06/1996SE |
| K960416 | Comfit MicropticKGO · Traditional | 04/26/1996SE |
Questions and answers
When was Comfit, Patient Examination Gloves cleared by the FDA?
Comfit, Patient Examination Gloves (K903746) received a 510(k) decision of Substantially Equivalent on September 5, 1990, 23 days after the submission was received.
What is the product code of K903746?
The FDA product code is FMC – Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.