Atlas FDA

Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs

FDA 510(k) clearance K180221 · decided 2018-08-08

Clearance details

K-number
K180221
Device name
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
Applicant
Smart Glove Corporation Sdn. Bhd.
Decision
Substantially Equivalent
Date received
2018-01-25
Decision date
2018-08-08
Days to decision
195 days
Clearance type
Traditional
Product code
KGO
Device class
1
Regulation number
878.4460
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Klang, MY
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.