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"

1–24 of 62

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

Cleared Oct 02, 2020

Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...

Hartalega Sdn Bhd

General Hospital · 98d

Cleared Aug 05, 2020

Sterile Nitrile Powder Free Examination Glove Tested for Use with...

Hartalega Sdn Bhd

General Hospital · 58d

Cleared Jun 01, 2020

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs...

Hartalega Sdn Bhd

General Hospital · 59d

Cleared Sep 26, 2019

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...

Hartalega NGC Sdn. Bhd.

General Hospital · 213d

Cleared Nov 16, 2018

Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use...

Hartalega Sdn Bhd

General Hospital · 249d

Cleared Nov 02, 2018

Sterile Nitrile Powder Free Examination Glove Tested for Use with...

Hartalega Sdn Bhd

General Hospital · 221d

Cleared Aug 17, 2018

Biodegradable Nitrile Powder Free Examination Glove (Blue)

Hartalega Sdn Bhd

General Hospital · 277d

Cleared Aug 10, 2018

Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green

Hartalega Sdn Bhd

General Hospital · 151d

Cleared Jun 14, 2018

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with...

Hartalega Sdn Bhd

General Hospital · 108d

Cleared Dec 12, 2017

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...

Hartalega Sdn Bhd

General Hospital · 74d

Cleared Oct 12, 2017

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...

Hartalega Sdn Bhd

General Hospital · 111d

Cleared May 05, 2017

POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)

Hartalega Sdn Bhd

General Hospital · 108d

Cleared Feb 08, 2017

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

Hartalega Sdn Bhd

General Hospital · 154d

Cleared Jan 09, 2017

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for...

Hartalega Sdn Bhd

General Hospital · 95d

Cleared Jan 09, 2017

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...

Hartalega Sdn Bhd

General Hospital · 95d

Cleared Aug 04, 2016

Latex Powder Free Polymer Coated Examination Glove with Protein Labeling...

Hartalega Sdn Bhd

General Hospital · 115d

Cleared Aug 04, 2016

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...

Hartalega Sdn Bhd

General Hospital · 157d

Cleared Jul 28, 2016

POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE...

Hartalega Sdn Bhd

General Hospital · 108d

Cleared Jun 09, 2015

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

Hartalega Sdn Bhd

General Hospital · 92d

Cleared Apr 23, 2015

Nitrile Powder Free Examination Gloves (Orange) Tested For Use With...

Hartalega Sdn Bhd

General Hospital · 93d

Cleared Dec 18, 2014

Nitrile Powder Free Examination Glove (Blue)

Hartalega Sdn Bhd

General Hospital · 94d

Cleared Sep 12, 2014

NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN...

Hartalega Sdn Bhd

General Hospital · 246d

Cleared May 28, 2014

NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN...

Hartalega Sdn Bhd

General Hospital · 156d

Cleared May 28, 2014

LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN...

Hartalega Sdn Bhd

General Hospital · 156d