Hartalega Sdn Bhd
FDA 510(k) medical device clearances.
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.