Atlas FDA

DISPOSABLE BEARD COVER

FDA 510(k) clearance K904276 · decided 1990-11-21

Clearance details

K-number
K904276
Device name
DISPOSABLE BEARD COVER
Applicant
Anago, Inc.
Decision
Substantially Equivalent
Date received
1990-09-19
Decision date
1990-11-21
Days to decision
63 days
Clearance type
Traditional
Product code
FXY
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (K222214)Thi Total Healthcare Innovation GmbH2023-10-17
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover (K200493)Stryker Corporation2020-03-21
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (K140588)Stryker Corporation2014-06-26
HOOD, OPERATING, SURGICAL (K904969)Chicago Assoc. For Retarded Citizens1990-12-12
STERI-SHIELD (K903533)Biomedical Devices, Inc.1990-10-19
STERI-SHIELD (K902677)Biomedical Devices, Inc.1990-08-17
CARETEX SURGEON'S HOODS (K880431)James River Corp.1988-02-24
HOOD, CLARION SURGEONS (K770261)Sherwood Medical Industries1977-03-01
HOOD & BEARD COVER, CLARION SURGEON'S (K770257)Sherwood Medical Industries1977-02-25
P.S.M. SURGICAL HOOD (K761070)The Owenby Co.1976-12-30
BARRIER FASHION BONNET (K760865)Surgikos, Inc.1976-11-03
BARRIER SURGICAL HOOD (K760855)Surgikos, Inc.1976-11-03

Recalls involving this device

No recalls on record reference this clearance.