Atlas FDA

PERRY NATURAL POWDER FREE GLOVES

FDA 510(k) clearance K912797 · decided 1991-07-19

Clearance details

K-number
K912797
Device name
PERRY NATURAL POWDER FREE GLOVES
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
1991-06-25
Decision date
1991-07-19
Days to decision
24 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
Massillon, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10