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FDA 510(k)

TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE

K-Number: K992122 · 1999-07-15

ApplicantMaxxim Medical
Decision Date1999-07-15
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Maxxim Medical. It received FDA 510(k) clearance on 1999-07-15 under 510(k) number K992122. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE?

TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1999-07-15. The listed applicant is Maxxim Medical. The 510(k) number is K992122.

When did TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE receive FDA 510(k) clearance?

TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE received FDA 510(k) clearance on 1999-07-15, under 510(k) number K992122.

Who is the listed applicant for TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE?

The FDA 510(k) record lists Maxxim Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE?

The FDA product code for TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE is LYZ.

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Other records listing Maxxim Medical 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.

K023236SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVESK021452STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVEK011905SNIPER ELITE MODEL-OR-E3872XX SERIESK002847INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XXK010297SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)K002933STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES

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Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

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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