Product Code: FYF FDA class 1 21 CFR 878.4040

Cap, Surgical

General, Plastic Surgery

A surgical cap is a head covering worn by operating room personnel to confine hair and reduce contamination of the sterile surgical field, forming part of standard surgical attire. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FYF, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

291

Registration Numbers

291

Unique Applicants

Years Active

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Basic Information

Product Code: FYF
Device Class: FDA class 1
Regulation Number: 878.4040
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972227	SHOE COVER	Sep 09, 1997	Substantially Equivalent	American Seal Co.
K955833	NIOMED SURGICAL CAPS	Mar 15, 1996	Substantially Equivalent	Amerasia Corp.
K954556	SURGICAL CAP	Mar 12, 1996	Substantially Equivalent	Thai Disposable Products Co., Ltd.
K954455	NIOMED BOUFFANT CAPS	Jan 23, 1996	Substantially Equivalent	Amerasia Corp.
K954454	NIOMED SURGICAL HOOD	Jan 23, 1996	Substantially Equivalent	Amerasia Corp.
K953879	SURGEON'S CAP	Jan 05, 1996	Substantially Equivalent	American Threshold Industries, Inc.
K953878	BOUFFANT CAP	Jan 05, 1996	Substantially Equivalent	American Threshold Industries, Inc.
K913700	DISPOSABLE BOUFFANT CAP	Oct 04, 1991	Substantially Equivalent	Gem Nonwovews, Inc.
K882346	INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD	Jun 30, 1988	Substantially Equivalent	Nordbye, Milchman, Barlage
K882284	SURGEONS CAP	Jun 23, 1988	Substantially Equivalent	A Plus International, Inc.
K882283	BOUFFANT CAP	Jun 23, 1988	Substantially Equivalent	A Plus International, Inc.
K880481	CARETEX SURGEON'S CAPS	Feb 24, 1988	Substantially Equivalent	James River Corp.
K875261	KIMBERLY-CLARK FULL COVERAGE HOOD	Jan 22, 1988	Substantially Equivalent	Kimberly-Clark Corp.
K874066	SURGICAL CAPS	Nov 04, 1987	Substantially Equivalent	Interpro Intl., Inc.
K873830	TECNOL SURGEON'S CAP	Oct 23, 1987	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K870618	VARIOUS TYPES OF SURGICAL GARMENTS	Mar 09, 1987	Substantially Equivalent	Kin Yuh Hung Co., Ltd.
K870617	VARIOUS TYES OF SURGICAL GARMENTS	Mar 09, 1987	Substantially Equivalent	Greene International Corp.
K863359	BOUFFANT-STYLE SURGICAL CAP	Sep 29, 1986	Substantially Equivalent	Kimberly-Clark Corp.
K851558	SURGICAL CAP CALOT	Apr 30, 1985	Substantially Equivalent	Roseburg SA
K844704	CAPS (O.R. NURSE, SURGICAL)	Jan 10, 1985	Substantially Equivalent	Medicon, Inc.
K831357	BOUNDARY HEADWEAR	Jun 02, 1983	Substantially Equivalent	Procter & Gamble Mfg. Co.
K810199	DISPOSABLE SURGERY CAPS & HOODS	Feb 13, 1981	Substantially Equivalent	Anago, Inc.
K802186	DISPOSABLE NURSES CAP	Sep 26, 1980	Substantially Equivalent	Anago, Inc.
K800810	FLARE DIS. NONWOVEN HEAD COVERS	May 20, 1980	Substantially Equivalent	Flare Products, Inc.
K800511	SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP	Apr 16, 1980	Substantially Equivalent	American Convertors Div., American Pharmaseal
K770260	CAP, CLARION NURSES OR (TECHNIC)	Mar 07, 1977	Substantially Equivalent	Sherwood Medical Industries
K770259	CAP, CLARION SURGEON'S	Mar 07, 1977	Substantially Equivalent	Sherwood Medical Industries
K770258	CAP, CLARION NURSES, STYLE BOUFFANT 21	Mar 07, 1977	Substantially Equivalent	Sherwood Medical Industries
K761071	P.S.M. JUSTA KAP	Dec 30, 1976	Substantially Equivalent	The Owenby Co.
K761069	P.S.M. BOTIQUE CAP	Dec 30, 1976	Substantially Equivalent	The Owenby Co.
K761068	P.S.M. BOUFFANT CAP	Dec 30, 1976	Substantially Equivalent	The Owenby Co.
K760861	SURGICAL CORP.	Nov 03, 1976	Substantially Equivalent	Surgikos, Inc.