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FDA 510(k)

MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE

K-Number: K050071 · 2005-05-11

ApplicantH.B.M. USA Co.,Inc.
Decision Date2005-05-11
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is H.B.M. USA Co.,Inc.. It received FDA 510(k) clearance on 2005-05-11 under 510(k) number K050071. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE?

MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE is a medical device that received FDA 510(k) clearance on 2005-05-11. The listed applicant is H.B.M. USA Co.,Inc.. The 510(k) number is K050071.

When did MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE receive FDA 510(k) clearance?

MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE received FDA 510(k) clearance on 2005-05-11, under 510(k) number K050071.

Who is the listed applicant for MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE?

The FDA 510(k) record lists H.B.M. USA Co.,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE?

The FDA product code for MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE is KGO.

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Related Devices (Code: KGO)

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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