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

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

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

OPJ is the FDA product code for Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OPJ
Device name
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
FDA definition
A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
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
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 147 companies shown, in name order