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FDA 510(k)

CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES

K-Number: K892246 · 1989-08-21

ApplicantB Und J Instrument, Inc.
Decision Date1989-08-21
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is B Und J Instrument, Inc.. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K892246. 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 CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES?

CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is B Und J Instrument, Inc.. The 510(k) number is K892246.

When did CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 1989-08-21, under 510(k) number K892246.

Who is the listed applicant for CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists B Und J Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES?

The FDA product code for CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES is LYZ.

Related Clinical Trials

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.

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Other records listing B Und J Instrument, 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.

K892245CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES

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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