Posi-Prene Edge Pink

GUDID 00850006162376

P3400PF/M, Posi-Prene Pink, 4 Gram, C.R., Pink, Powder Free, Examination Glove, Size Medium, 100/Box

Clinical Supply Company

Polychloroprene examination/treatment glove, non-powdered
Primary Device ID00850006162376
NIH Device Record Key21c72021-b3bc-479a-bb95-d1c9288efa25
Commercial Distribution StatusIn Commercial Distribution
Brand NamePosi-Prene Edge Pink
Version Model NumberP3400PF/M
Company DUNS620679308
Company NameClinical Supply Company
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850006162376 [Package]
Contains: 00850006162543
Package: Case [100 Units]
In Commercial Distribution
GS100850006162543 [Primary]

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-04-01
Device Publish Date2026-03-24

On-Brand Devices [Posi-Prene Edge Pink]

00850006162376P3400PF/M, Posi-Prene Pink, 4 Gram, C.R., Pink, Powder Free, Examination Glove, Size Medium, 100
00850006162369P3400PF/S, Posi-Prene Edge Pink, 4 Gram, C.R., Pink, Powder Free, Examination Glove, Size Small,
00850006162352P3400PF/XS, Posi-Prene Edge Pink, 4 Gram, C.R., Pink, Powder Free, Examination Glove, Size Extra

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