Medical Device Manufacturer · MY , Kuala Lumpur

Hartalega Sdn Bhd - FDA 510(k) Cleared Devices

61 submissions · 61 cleared · Since 1989
61
Total
61
Cleared
0
Denied

Hartalega Sdn Bhd has 61 FDA 510(k) cleared general hospital devices. Based in Kuala Lumpur, MY.

Historical record: 61 cleared submissions from 1989 to 2020.

Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Hartalega Sdn Bhd

61 devices
1-12 of 61
Cleared Oct 02, 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...
K201748 · KGO
General Hospital · 98d
Cleared Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K201531 · LZA
General Hospital · 58d
Cleared Jun 01, 2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs...
K200897 · KGO
General Hospital · 59d
Cleared Nov 16, 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use...
K180645 · LZA
General Hospital · 249d
Cleared Nov 02, 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K180786 · LZA
General Hospital · 221d
Cleared Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509 · LZA
General Hospital · 277d
Cleared Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644 · LZA
General Hospital · 151d
Cleared Jun 14, 2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with...
K180505 · LZA
General Hospital · 108d
Cleared Dec 12, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K173137 · LZA
General Hospital · 74d
Cleared Oct 12, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
K171874 · LZA
General Hospital · 111d
Cleared May 05, 2017
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
K170152 · KGO
General Hospital · 108d
Cleared Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491 · LZA
General Hospital · 154d

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