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FDA 510(k)

SIME SURGICAL POWDERFREE

K-Number: K954025 · 1995-11-15

ApplicantSime Health, Ltd.
Decision Date1995-11-15
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIME SURGICAL POWDERFREE is the device name listed in this FDA 510(k) record. The listed applicant is Sime Health, Ltd.. It received FDA 510(k) clearance on 1995-11-15 under 510(k) number K954025. 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 SIME SURGICAL POWDERFREE?

SIME SURGICAL POWDERFREE is a medical device that received FDA 510(k) clearance on 1995-11-15. The listed applicant is Sime Health, Ltd.. The 510(k) number is K954025.

When did SIME SURGICAL POWDERFREE receive FDA 510(k) clearance?

SIME SURGICAL POWDERFREE received FDA 510(k) clearance on 1995-11-15, under 510(k) number K954025.

Who is the listed applicant for SIME SURGICAL POWDERFREE?

The FDA 510(k) record lists Sime Health, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIME SURGICAL POWDERFREE?

The FDA product code for SIME SURGICAL POWDERFREE is KGO.

Related Clinical Trials

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Other records listing Sime Health, Ltd. 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.

K954051SIME POWDERFREE PLUSK932985AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFIK932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFIK932983COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932982SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K940797SIME SURGICAL LATEX GLOVE

View all 11 devices →

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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