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FDA 510(k)

STERILE LUBRICATING JELLY

K-Number: K112110 · 2012-04-10

ApplicantJianerkang Medical Dressing Company
Decision Date2012-04-10
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is Jianerkang Medical Dressing Company. It received FDA 510(k) clearance on 2012-04-10 under 510(k) number K112110. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE LUBRICATING JELLY?

STERILE LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 2012-04-10. The listed applicant is Jianerkang Medical Dressing Company. The 510(k) number is K112110.

When did STERILE LUBRICATING JELLY receive FDA 510(k) clearance?

STERILE LUBRICATING JELLY received FDA 510(k) clearance on 2012-04-10, under 510(k) number K112110.

Who is the listed applicant for STERILE LUBRICATING JELLY?

The FDA 510(k) record lists Jianerkang Medical Dressing Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE LUBRICATING JELLY?

The FDA product code for STERILE LUBRICATING JELLY is KMJ.

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Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal CorporationK092488DYNAREX STERILE LUBRICATING JELLYDynarex Corporation

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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