Sempermed skySense BBLN301

GUDID 00841277110135

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Primary Device ID	00841277110135
NIH Device Record Key	2e9b5f44-aca1-47b3-aacc-169f93d7d8fa
Commercial Distribution Discontinuation	2025-03-17
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Sempermed skySense
Version Model Number	BBLN301
Catalog Number	BBLN301
Company DUNS	004072158
Company Name	SEMPERMED USA, INC.
Device Count	300
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00841277110074 [Primary]
GS1	00841277110135 [Unit of Use]

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

Steralize Prior To Use	false
Device Is Sterile	false

00841277110173	Sempermed skySense, 300 Nitrile Exam Glove Powder Free- XL
00841277110166	Sempermed skySense, 300 Nitrile Exam Glove Powder Free- L
00841277110159	Sempermed skySense, 300 Nitrile Exam Glove Powder Free- M
00841277110142	Sempermed skySense, 300 Nitrile Exam Glove Powder Free- S
00841277110135	Sempermed skySense, 300 Nitrile Exam Glove Powder Free- XS