Hartalega Sdn Bhd
Hartalega Sdn Bhd holds FDA 510(k) medical device clearances, first cleared 1989, most recent 2020.
Top product codes for Hartalega Sdn Bhd
Recent clearances by Hartalega Sdn Bhd
- K201748 — Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
- K201531 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K200897 — Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
- K180645 — Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
- K180786 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
- K173509 — Biodegradable Nitrile Powder Free Examination Glove (Blue)
- K180644 — Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
- K180505 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
- K173137 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
- K171874 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
- K170152 — POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
- K162491 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- K162818 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
- K162819 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
- K160560 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
- K161006 — Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
- K161008 — POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
- K150593 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- K150103 — Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
- K142588 — Nitrile Powder Free Examination Glove (Blue)
- K140050 — NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
- K133953 — LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
- K133956 — NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
- K132006 — STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
- K130473 — NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
- K123368 — LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
- K120336 — NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
- K110758 — NITRILE POWDER FREE EXAMINATION GLOVES
- K091652 — NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
- K071910 — NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
- K062950 — POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
- K063046 — NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
- K052583 — BLUE POWDER FREE NITRILE EXAMINATION GLOVES
- K052177 — POWDER FREE STERILE LATEX SURGICAL GLOVES
- K051777 — NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
- K051778 — NITRILE POWDERED EXAMINATION GLOVES (BLUE)
- K050277 — CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
- K050214 — NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
- K050215 — NITRILE POWDERED EXAMINATION GLOVES (WHITE)
- K041391 — FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K022671 — FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
- K002593 — POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K001959 — POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K993760 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
- K993722 — BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
- K993725 — GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
- K991616 — CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K990283 — BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K980572 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
- K980318 — POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
- K973778 — POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
- K973871 — LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
- K963804 — PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
- K964148 — PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES
- K954416 — POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
- K954221 — POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
- K954415 — PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K945885 — PATIENT EXAMINATION GLOVES
- K936062 — POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24
- K936063 — POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929
- K892104 — PATIENT EXAMINATION GLOVES (LATEX)
Data sourced from openFDA. This site is unofficial and independent of the FDA.