Customed 712057693048

• FDA 510(k) K010198 decided 23 Feb 2001 Active
• FDA GUDID UDI-DI M20890030487 listed 23 Sep 2016 Listed

1. 23 Feb 2001 Cleared FDA 510(k) K010198
2. 23 Sep 2016 Listed FDA GUDID M20890030487

Trade name

Customed

Generic name

Hevea-latex surgical glove, powdered

Model / Ref / Catalog

712057693048, 9003048

Primary DI / UDI-DI

M20890030487

510(k) Number

K010198 ↗

FDA product code

KGO

GMDN term

Hevea-latex surgical glove, powdered

Device class

Class I

Regulation number

878.4460

GUDID distribution status

In Commercial Distribution

Size

Circumference — 6.5 Inch

Category: Hevea-latex surgical glove, powdered

Other devices filed under FDA product code KGO (Surgeon'S Gloves).

• STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) by SUPERMAX GLOVE MANUFACTURING SDN BHD
• PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE by WRP Asia Pacific Sdn. Bhd.
• SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM by Terang Nusa Sdn Bhd
• LATEX SURGICAL STERILE GLOVES by Mirage Medical & Chemical, Inc.
• BIO-GUARD LATEX SURGICAL GLOVES by Network Medical Systems, Inc.
• PERRY NATURAL POWDER FREE GLOVES by Smith & Nephew, Inc.
• STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) by Boston Medical Corp.
• Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) by Cardinalhealth
• CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE) by Select Sources, Inc.
• DAEWOO LATEX SURGICAL GLOVE by California Ent.

• Sterile Suture Removal Kit

  Class I

  FDA 510(k) K925015 Active Cleared 7 Jun 1993

• Customed 712057831816

  Class II

  FDA 510(k) K092338 Active Cleared 27 May 2011 GUDID on market

• Customed 712057102985

  Class I

  GUDID on market

• Customed 712057462213

  Class II

  FDA 510(k) K081633 Active Cleared 11 Aug 2008 GUDID on market

See all devices from Customed, Inc. →