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

Nibong Tebal, Pulau Pinang, MY

Alliance Rubber Products Sdn. Bhd. appears in FDA device records in Nibong Tebal, Pulau Pinang, MY. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 12 510(k) clearances for Alliance Rubber Products Sdn. Bhd. between 1990 and 2000. The busiest year on record is 1999, with 6. The most recent is 2000, with 1.

Clearances by year, as a table
510(k) clearance decisions for Alliance Rubber Products Sdn. Bhd., by decision year
YearClearances
19901
19972
19982
19996
20001
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K002701POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)LYYSubstantially Equivalent
K992870POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEILYYSubstantially Equivalent
K991981NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLORLZASubstantially Equivalent
K990486NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.LZASubstantially Equivalent
K990485NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLORLZASubstantially Equivalent
K990427ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREELZASubstantially Equivalent
K990453NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLORLZASubstantially Equivalent
K983146ARSOFTLZASubstantially Equivalent
K980589AR SAFE NITRILE EXAMINATION GLOVESLZASubstantially Equivalent
K972801ALLIANCE RUBBER, EC-GRIPLYYSubstantially Equivalent
K971183GOLD FINGERSLYYSubstantially Equivalent
K896673LATEX PATIENT EXAMINATION GLOVESLYYSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

Verification record

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