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"

25–48 of 62

Search insights Median review: 108d Cleared: 100% Top manufacturer: Hartalega Sdn Bhd Lead specialty: General Hospital

Cleared Nov 07, 2013

STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER...

Hartalega Sdn Bhd

General Hospital · 129d

Cleared Jul 05, 2013

NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)

Hartalega Sdn Bhd

General Hospital · 133d

Cleared May 07, 2013

LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT

Hartalega Sdn Bhd

General Hospital · 187d

Cleared Jun 25, 2012

NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE...

Hartalega Sdn Bhd

General Hospital · 143d

Cleared Aug 12, 2011

NITRILE POWDER FREE EXAMINATION GLOVES

Hartalega Sdn Bhd

General Hospital · 147d

Cleared Sep 04, 2009

NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY...

Hartalega Sdn Bhd

General Hospital · 87d

Cleared Sep 06, 2007

NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE...

Hartalega Sdn Bhd

General Hospital · 57d

Cleared Dec 21, 2006

POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)

Hartalega Sdn Bhd

General Hospital · 83d

Cleared Nov 17, 2006

NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)

Hartalega Sdn Bhd

General Hospital · 44d

Cleared Jun 14, 2006

BLUE POWDER FREE NITRILE EXAMINATION GLOVES

Hartalega Sdn Bhd

General Hospital · 267d

Cleared Dec 09, 2005

POWDER FREE STERILE LATEX SURGICAL GLOVES

Hartalega Sdn Bhd

General Hospital · 121d

Cleared Aug 12, 2005

NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)

Hartalega Sdn Bhd

General Hospital · 42d

Cleared Jul 26, 2005

NITRILE POWDERED EXAMINATION GLOVES (BLUE)

Hartalega Sdn Bhd

General Hospital · 25d

Cleared Jun 07, 2005

CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)

Hartalega Sdn Bhd

General Hospital · 120d

Cleared Mar 16, 2005

NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)

Hartalega Sdn Bhd

General Hospital · 44d

Cleared Mar 11, 2005

NITRILE POWDERED EXAMINATION GLOVES (WHITE)

Hartalega Sdn Bhd

General Hospital · 39d

Cleared Jul 09, 2004

FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES

Hartalega Sdn Bhd

General Hospital · 45d

Cleared Nov 18, 2002

FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES

Hartalega Sdn Bhd

General Hospital · 98d

Cleared Nov 29, 2000

POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF...

Hartalega Sdn Bhd

General Hospital · 100d

Cleared Jul 26, 2000

POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM...

Hartalega Sdn Bhd

General Hospital · 29d

Cleared May 15, 2000

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200...

Hartalega Sdn Bhd

General Hospital · 189d

Cleared Nov 23, 1999

GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...

Hartalega Sdn Bhd

General Hospital · 20d

Cleared Nov 23, 1999

BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...

Hartalega Sdn Bhd

General Hospital · 20d

Cleared Jul 14, 1999

CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING...

Hartalega Sdn Bhd

General Hospital · 65d