Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

13 results for "Indonesia"
1–13 of 13
Search insights Median review: 89d Cleared: 100% Top manufacturer: Pt. Smartglove Indonesia Lead specialty: General Hospital
Cleared Jul 18, 2014
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
K133699 · LZA
Pt. Smartglove Indonesia
General Hospital · 227d
Cleared Sep 07, 2010
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH...
K101630 · LZA
Pt. Smartglove Indonesia
General Hospital · 89d
Cleared Jul 01, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY...
K101293 · LZA
Pt. Smartglove Indonesia
General Hospital · 52d
Cleared Oct 19, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
K092034 · LZA
Pt. Smartglove Indonesia
General Hospital · 105d
Cleared Aug 20, 2004
POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
K041848 · LZA
Pt. Smartglove Indonesia
General Hospital · 43d
Cleared Aug 12, 2004
POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
K040792 · LYY
Pt. Smartglove Indonesia
General Hospital · 136d
Cleared Jun 03, 2004
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K040791 · LZA
Pt. Smartglove Indonesia
General Hospital · 66d
Cleared Mar 25, 2003
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
K030284 · LZA
Pt. Smartglove Indonesia
General Hospital · 57d
Cleared Feb 27, 2003
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
K030406 · LZA
Pt. Smartglove Indonesia
General Hospital · 20d
Cleared Feb 27, 2003
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50...
K030112 · LYY
Pt. Smartglove Indonesia
General Hospital · 45d
Cleared Feb 19, 2003
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
K022814 · LZA
Pt. Smartglove Indonesia
General Hospital · 177d
Cleared Feb 13, 2003
MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX
K022815 · LYY
Pt. Smartglove Indonesia
General Hospital · 171d
Cleared Sep 20, 1993
SUNGLASSES
K933074 · HQZ
P.T. Sun and Young Indonesia Sunglasses
Ophthalmic · 89d