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FDA 510(k)

PRISTINE XTRA, SURGEON'S GLOVE

K-Number: K883244 · 1988-08-23

ApplicantJapan World Medical Supply
Decision Date1988-08-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRISTINE XTRA, SURGEON'S GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Japan World Medical Supply. It received FDA 510(k) clearance on 1988-08-23 under 510(k) number K883244. 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 PRISTINE XTRA, SURGEON'S GLOVE?

PRISTINE XTRA, SURGEON'S GLOVE is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is Japan World Medical Supply. The 510(k) number is K883244.

When did PRISTINE XTRA, SURGEON'S GLOVE receive FDA 510(k) clearance?

PRISTINE XTRA, SURGEON'S GLOVE received FDA 510(k) clearance on 1988-08-23, under 510(k) number K883244.

Who is the listed applicant for PRISTINE XTRA, SURGEON'S GLOVE?

The FDA 510(k) record lists Japan World Medical Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRISTINE XTRA, SURGEON'S GLOVE?

The FDA product code for PRISTINE XTRA, SURGEON'S 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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