Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE

K-Number: K082443 · 2008-09-26

ApplicantRich Mountain Medical Products, Inc.
Decision Date2008-09-26
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Rich Mountain Medical Products, Inc.. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K082443. 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 DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE?

DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is Rich Mountain Medical Products, Inc.. The 510(k) number is K082443.

When did DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE receive FDA 510(k) clearance?

DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE received FDA 510(k) clearance on 2008-09-26, under 510(k) number K082443.

Who is the listed applicant for DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE?

The FDA 510(k) record lists Rich Mountain Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE?

The FDA product code for DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE 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 Rich Mountain Medical Products, 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.

K120190DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLORK082448DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDEREDK082447DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREEK082444DISPOSABLE VINYL EXAMINATION GLOVE, POWDEREDK081539DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLORK081535DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

View all 7 devices →

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.

↑