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FDA 510(k)

LATEX GLOVE APPLICATION AND REMOVAL SYSTEM

K-Number: K905127 · 1991-01-30

ApplicantSuccess Builders Intl., Inc.
Decision Date1991-01-30
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX GLOVE APPLICATION AND REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Success Builders Intl., Inc.. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K905127. The device is classified under product code FMC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX GLOVE APPLICATION AND REMOVAL SYSTEM?

LATEX GLOVE APPLICATION AND REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Success Builders Intl., Inc.. The 510(k) number is K905127.

When did LATEX GLOVE APPLICATION AND REMOVAL SYSTEM receive FDA 510(k) clearance?

LATEX GLOVE APPLICATION AND REMOVAL SYSTEM received FDA 510(k) clearance on 1991-01-30, under 510(k) number K905127.

Who is the listed applicant for LATEX GLOVE APPLICATION AND REMOVAL SYSTEM?

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

What is the FDA product code for LATEX GLOVE APPLICATION AND REMOVAL SYSTEM?

The FDA product code for LATEX GLOVE APPLICATION AND REMOVAL SYSTEM is FMC.

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 Success Builders Intl., 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.

K905177STAT(TM) GLOVE

Related Devices (Code: FMC)

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.

K042618LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)La Glove (M) Sdn. Bhd.K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.

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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