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FDA 510(k)

SURGICAL GOWN #2001

K-Number: K891211 · 1989-04-14

ApplicantPro-Safe Professional Linens, Inc.
Decision Date1989-04-14
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWN #2001 is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Safe Professional Linens, Inc.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K891211. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL GOWN #2001?

SURGICAL GOWN #2001 is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Pro-Safe Professional Linens, Inc.. The 510(k) number is K891211.

When did SURGICAL GOWN #2001 receive FDA 510(k) clearance?

SURGICAL GOWN #2001 received FDA 510(k) clearance on 1989-04-14, under 510(k) number K891211.

Who is the listed applicant for SURGICAL GOWN #2001?

The FDA 510(k) record lists Pro-Safe Professional Linens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL GOWN #2001?

The FDA product code for SURGICAL GOWN #2001 is FYA.

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Other records listing Pro-Safe Professional Linens, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K891210POCKETED WRAPS #3009 A,B,CK891216DENTAL EQUIPMENT PROTECTION DEVICESK891215FAST WRAP #M 101K891212APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPEK891213SURGICAL INSTRUMENT POUCH #M102K891214DENTAL SURGICAL WRAP #3007 A,B,C

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Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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