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FDA 510(k)

STAT(TM) GLOVE

K-Number: K905177 · 1991-01-30

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

Device Summary

STAT(TM) GLOVE 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 K905177. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT(TM) GLOVE?

STAT(TM) GLOVE 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 K905177.

When did STAT(TM) GLOVE receive FDA 510(k) clearance?

STAT(TM) GLOVE received FDA 510(k) clearance on 1991-01-30, under 510(k) number K905177.

Who is the listed applicant for STAT(TM) GLOVE?

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 STAT(TM) GLOVE?

The FDA product code for STAT(TM) GLOVE is LZC.

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 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.

K905127LATEX GLOVE APPLICATION AND REMOVAL SYSTEM

Related Devices (Code: LZC)

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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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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