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FDA 510(k)

PROMAX SURGICAL DRAPES AND COVERS

K-Number: K980183 · 1998-02-26

ApplicantStandard Textile Co., Inc.
Decision Date1998-02-26
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROMAX SURGICAL DRAPES AND COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 1998-02-26 under 510(k) number K980183. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROMAX SURGICAL DRAPES AND COVERS?

PROMAX SURGICAL DRAPES AND COVERS is a medical device that received FDA 510(k) clearance on 1998-02-26. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K980183.

When did PROMAX SURGICAL DRAPES AND COVERS receive FDA 510(k) clearance?

PROMAX SURGICAL DRAPES AND COVERS received FDA 510(k) clearance on 1998-02-26, under 510(k) number K980183.

Who is the listed applicant for PROMAX SURGICAL DRAPES AND COVERS?

The FDA 510(k) record lists Standard Textile Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROMAX SURGICAL DRAPES AND COVERS?

The FDA product code for PROMAX SURGICAL DRAPES AND COVERS is KKX.

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Other records listing Standard Textile Co., 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.

K241214ProPel SG3™ Surgical GownK172207Standard Supreme Sterilization WrapperK162162Barrier Supreme Sterilization WrapperK060181COMPE1 1 -PLY SURGICAL GOWNSK041653COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSK041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

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Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, 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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