Disposable Bouffant Cap

FDA 510(k) K913700 · Gem Nonwovews, Inc.

Substantially Equivalent

510(k) numberK913700

Submission

Device name
Disposable Bouffant Cap
Applicant
Gem Nonwovews, Inc.
Huntsville, AL, US
Received
August 19, 1991
Decision date
October 4, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FYF – Cap, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

Other 510(k)s with product code FYF

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K972227Shoe CoverFYF · Traditional American Seal Co.09/09/1997SE
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K954556Surgical CapFYF · Traditional Thai Disposable Products Co., Ltd.03/12/1996SE
K954455Niomed Bouffant CapsFYF · Traditional Amerasia Corp.01/23/1996SE
K954454Niomed Surgical HoodFYF · Traditional Amerasia Corp.01/23/1996SE
K953879Surgeon's CapFYF · Traditional American Threshold Industries, Inc.01/05/1996SE
K953878Bouffant CapFYF · Traditional American Threshold Industries, Inc.01/05/1996SE
K882346Instrument Protect-A-Caps, Aka: Tip/Instru. GuardFYF · Traditional Nordbye, Milchman, Barlage06/30/1988SE
K882284Surgeons CapFYF · Traditional A Plus International, Inc.06/23/1988SE
K882283Bouffant CapFYF · Traditional A Plus International, Inc.06/23/1988SE

More from A Plus International, Inc.

510(k)DeviceDecision
K913628Disposable Shoe CoverFXP · Traditional 10/04/1991SE

Questions and answers

When was Disposable Bouffant Cap cleared by the FDA?

Disposable Bouffant Cap (K913700) received a 510(k) decision of Substantially Equivalent on October 4, 1991, 46 days after the submission was received.

What is the product code of K913700?

The FDA product code is FYF – Cap, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.