FDA product code FMC: Patient Examination Glove
FMC is the FDA product code for patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. FDA has cleared 34 510(k) submissions under FMC, from 30 different applicants. The average 510(k) review took 77 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Patient Examination Glove |
| Device class | Class I |
| Regulation | 21 CFR 880.6250 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FMC clearance
Top FMC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Safeskin Corp. | 2 | 1994-05-18 |
| Phoenix Glove Co. | 2 | 1982-05-21 |
| Pollak (Intl.), Ltd. | 2 | 1980-09-09 |
| Jamar Health Products | 2 | 1978-01-26 |
| La Glove (M) Sdn. Bhd. | 1 | 2004-11-26 |
25 more applicants have FMC clearances. See the full list in Caduvo.
Most recent FMC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042618 | La Glove (M) Sdn. Bhd. | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) | 2004-11-26 | 60 |
| K014134 | Supergrade Healthcare Products Sdn. Bhd. | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) | 2002-01-22 | 36 |
| K992337 | Mexpo Intl., Inc. | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA | 1999-08-17 | 35 |
| K932405 | Safeskin Corp. | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | 1994-05-18 | 370 |
| K932404 | Safeskin Corp. | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | 1994-05-18 | 370 |
Recalls for FMC devices
openFDA lists no recalls for product code FMC.
Frequently asked questions
What is FDA product code FMC?
FMC is the FDA product code for patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.
What device class is FMC?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).
How long does a 510(k) take for product code FMC?
Across 34 cleared submissions the average was 77 days from receipt to decision (median 38).
Which companies have the most FMC clearances?
Safeskin Corp. (2); Phoenix Glove Co. (2); Pollak (Intl.), Ltd. (2); Jamar Health Products (2); La Glove (M) Sdn. Bhd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FMC
- Run a recall and safety report across every FMC manufacturer
- Watch product code FMC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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