510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Eco Medi Glove Sdn Bhd

Taiping Perak, MY

ECO MEDI GLOVE SDN BHD appears in FDA device records in Taiping Perak, MY. FDA records list 15 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 15 510(k) clearances for Eco Medi Glove Sdn Bhd between 2014 and 2024. The busiest year on record is 2014, with 4. The most recent is 2024, with 2.

Clearances by year, as a table
510(k) clearance decisions for Eco Medi Glove Sdn Bhd, by decision year
YearClearances
20144
20163
20171
20181
20201
20211
20221
20231
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric AcidLZASubstantially Equivalent
K232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZASubstantially Equivalent
K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimLZASubstantially Equivalent
K220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test ClaimLZASubstantially Equivalent
K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable ProteinKGOSubstantially Equivalent
K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs ClaimsLZASubstantially Equivalent
K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs ClaimsLZASubstantially Equivalent
K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy DrugsLZASubstantially Equivalent
K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy DrugsLZASubstantially Equivalent
K161320EMG Pink Nitrile Examination Glove Powder FreeLZASubstantially Equivalent
K152937EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint ScentedLZASubstantially Equivalent
K141579EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREELZASubstantially Equivalent
K141623EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIMLZASubstantially Equivalent
K141510EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)LZASubstantially Equivalent
K141590EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREELZASubstantially Equivalent

Registered establishments

FDA registered establishments for Eco Medi Glove Sdn Bhd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30107632233010763223ECO MEDI GLOVE SDN BHDLot 23826,. Jalan Tembaga Kuning, Taiping Perak 34600 MY2026
30164136343016413634ECO MEDI GLOVE SDN BHDLot 26910, Lorong Perusahaan 3/3, Taiping Perak 34600 MY2026
30215913193021591319ECO MEDI GLOVE SDN BHDPt 33500,Jalan Perusahaan 1, Taiping Perak 34600 MY2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain