FDA 510(k)

POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

K-Number: K052273 · 2005-09-30

Decision Date2005-09-30

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Pt Mahakarya Inti Buana. It received FDA 510(k) clearance on 2005-09-30 under 510(k) number K052273. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE?

POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE is a medical device that received FDA 510(k) clearance on 2005-09-30. The listed applicant is Pt Mahakarya Inti Buana. The 510(k) number is K052273.

When did POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE receive FDA 510(k) clearance?

POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE received FDA 510(k) clearance on 2005-09-30, under 510(k) number K052273.

Who is the listed applicant for POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE?

The FDA 510(k) record lists Pt Mahakarya Inti Buana as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE?

The FDA product code for POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE is LYY.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pt Mahakarya Inti Buana as applicant

K111300SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)K090464BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE K063581SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE K062313SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE K061233SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE K053305SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE

View all 9 devices →

Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.