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FDA 510(k)

INAMED PRO-TEC SILICONE SURGICAL GLOVES

K-Number: K894073 · 1989-09-18

ApplicantInamed Development Co.
Decision Date1989-09-18
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INAMED PRO-TEC SILICONE SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Inamed Development Co.. It received FDA 510(k) clearance on 1989-09-18 under 510(k) number K894073. 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 INAMED PRO-TEC SILICONE SURGICAL GLOVES?

INAMED PRO-TEC SILICONE SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1989-09-18. The listed applicant is Inamed Development Co.. The 510(k) number is K894073.

When did INAMED PRO-TEC SILICONE SURGICAL GLOVES receive FDA 510(k) clearance?

INAMED PRO-TEC SILICONE SURGICAL GLOVES received FDA 510(k) clearance on 1989-09-18, under 510(k) number K894073.

Who is the listed applicant for INAMED PRO-TEC SILICONE SURGICAL GLOVES?

The FDA 510(k) record lists Inamed Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INAMED PRO-TEC SILICONE SURGICAL GLOVES?

The FDA product code for INAMED PRO-TEC SILICONE SURGICAL GLOVES is KGO.

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Other records listing Inamed Development Co. 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.

K931548INAMED DEVELOPMENT ASPIRATION TIPK904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERK901764INAMED CONVERTIBLE DRAIN SYSTEMK901742INAMED SMALL DRAIN SYSTEMK894618INAMED RHEMO-D (TM) DILATORK896491INAMED CLOSED-WOUND DRAIN SYSTEM

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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.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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