510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FMCClass I

Patient Examination Glove

21 CFR 880.6250 / General Hospital
FDA source (opens on fda.gov)

FMC is the FDA product code for Patient Examination Glove, a class I device type, regulated under 21 CFR 880.6250. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FMC
Device name
Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
34
Ingested recalls
0

Clearances, product code FMC

By decision year
34 clearances under product code FMC with a decision year between 1977 and 2004, 1980 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FMC by decision year
YearClearances
19773
19783
19792
19804
19822
19832
19842
19882
19892
19903
19911
19922
19931
19942
19991
20021
20041

Applicants with the most clearances

Product code FMC
Applicants holding the most 510(k) clearances under product code FMC
ApplicantClearances
Jamar Health Products, Inc.2
Phoenix Glove Co.2
Pollak (Intl.).ltd2
Safeskin Corp.2
A & A Medical, Inc.1
Abco Dealers, Inc.1
American Hospital Supply1
American Medical Disposable, Inc.1
Ansell, Inc.1
Arbrook Mfg. Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code