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FDA 510(k)

BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)

K-Number: K891835 · 1989-06-22

ApplicantAssociated Ent., Inc.
Decision Date1989-06-22
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) is the device name listed in this FDA 510(k) record. The listed applicant is Associated Ent., Inc.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K891835. 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 BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)?

BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Associated Ent., Inc.. The 510(k) number is K891835.

When did BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) receive FDA 510(k) clearance?

BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) received FDA 510(k) clearance on 1989-06-22, under 510(k) number K891835.

Who is the listed applicant for BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)?

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

What is the FDA product code for BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)?

The FDA product code for BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Associated Ent., 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.

K924837DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DETK915636GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.K891836BUD BRAND PATIENT EXAMINATION GLOVES (LATEX)

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

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

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