Perusahaan Getah Asas Sdn. Bhd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 30 Latest Nov 29, 2010

Perusahaan Getah Asas Sdn. Bhd. has 0 FDA recalls, 0 inspections, 30 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Perusahaan Getah Asas Sdn. Bhd." is on file.

What these totals cover: FDA records filed under the name "Perusahaan Getah Asas Sdn. Bhd." and its spelling variant "Perusahaan Getah Asas Sdn. Bhd".

Latest 510(k)
Nov 29, 2010

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances30Nov 15, 2026File dated Nov 9, 2026Current
Inspections0Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

30 510(k) clearances from May 22, 1989 to Nov 29, 2010. Showing the 20 most recent. View all 30 510(k) clearances

K-NumberDeviceDate
K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL…Nov 29, 2010
K042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILEDec 16, 2004
K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDOct 22, 2003
K031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLOREDAug 1, 2003
K031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLOREDAug 1, 2003
K031591POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLOREDJun 26, 2003
K031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE…Jun 26, 2003
K031021CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVEJun 13, 2003
K030331ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIMMar 21, 2003
K030333LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIMMar 21, 2003
K030335ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLOREDMar 3, 2003
K024184POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLOREDJan 14, 2003
K023262POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR…Oct 28, 2002
K022701POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN ESep 17, 2002
K022601POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)Aug 26, 2002
K011271POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLOREDMay 8, 2001
K010719POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLORApr 10, 2001
K003737POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR…Feb 1, 2001
K002314LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS…Aug 17, 2000
K001529POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50…Jun 12, 2000

Perusahaan Getah Asas Sdn. Bhd. and the FDA: common questions

Has Perusahaan Getah Asas Sdn. Bhd. received an FDA warning letter?

No FDA warning letter addressed to the name "Perusahaan Getah Asas Sdn. Bhd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Perusahaan Getah Asas Sdn. Bhd. received an FDA Form 483?

FDA has not published a Form 483 for "Perusahaan Getah Asas Sdn. Bhd." in its reading room. FDA publishes some Form 483s, not all of them.

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