NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG— 510(k) K011370

Substantially Equivalent

Sgmp Co., Ltd.

FDA 510(k) clearance K011370 for NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG, Substantially Equivalent on 2001-06-07. Applicant: Sgmp Co., Ltd.. Device class: 1.

Clearance details

Applicant
Sgmp Co., Ltd.
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, NV, US
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