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

62 results for "Hartalega Sdn Bhd"
49–62 of 62
Search insights Median review: 108d Cleared: 100% Top manufacturer: Hartalega Sdn Bhd Lead specialty: General Hospital
Cleared Mar 09, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283 · LZA
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Mar 13, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · LYY
Hartalega Sdn Bhd
General Hospital · 24d
Cleared Mar 11, 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · LYY
Hartalega Sdn Bhd
General Hospital · 43d
Cleared Dec 11, 1997
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
K973871 · LYY
Hartalega Sdn Bhd
General Hospital · 62d
Cleared Dec 11, 1997
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K973778 · LYY
Hartalega Sdn Bhd
General Hospital · 69d
Cleared Feb 10, 1997
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804 · LZA
Hartalega Sdn Bhd
General Hospital · 140d
Cleared Feb 07, 1997
PATIENT EXAMINATION GLOVES
K964148 · LZA
Hartalega Sdn Bhd
General Hospital · 114d
Cleared Oct 11, 1996
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K954416 · LYY
Hartalega Sdn Bhd
General Hospital · 386d
Cleared May 03, 1996
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
K954221 · LYY
Hartalega Sdn Bhd
General Hospital · 235d
Cleared Mar 12, 1996
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K954415 · LYY
Hartalega Sdn Bhd
General Hospital · 173d
Cleared Mar 23, 1995
PATIENT EXAMINATION GLOVES
K945885 · LYY
Hartalega Sdn Bhd
General Hospital · 112d
Cleared Jun 06, 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929
K936063 · LYY
Hartalega Sdn Bhd
General Hospital · 168d
Cleared Jun 06, 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24
K936062 · LYY
Hartalega Sdn Bhd
General Hospital · 168d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892104 · LYY
Hartalega Sdn Bhd
General Hospital · 58d