Device
P3400PF/M, Posi-Prene Edge Pink, 4 Gram, C.R., Pink, Powder Free, Examination Glove, Size Medium, 200/Box
Manufacturer
Clinical Supply Company
Clinical Supply Company
Model: P3400PF/M
DI: 00850083634254
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
P3400PF/M, Posi-Prene Edge Pink, 4 Gram, C.R., Pink, Powder Free, Examination Glove, Size Medium, 200/Box
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a37e9ada-65c1-4fa9-a0df-6581f6138ebc
Distribution Status:
In Commercial Distribution
DUNS Number:
620679308
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
00850083634247
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
200
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850083634254
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850083634254
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 56288
Name: Polychloroprene examination/treatment glove, non-powdered
Definition:
A device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.
FDA Product Codes
LZA
Polymer Patient Examination Glove
Device Sizes
Device Size - Size Text:
Medium
Device Size - Size Type:
Device Size Text, specify
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling Low - @attributes - Value:
50
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value:
100
Storage Handling - Storage Handling Type:
Storage Environment Temperature