Sri Johani 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 23 Latest Dec 3, 1999

Sri Johani Sdn. Bhd. has 0 FDA recalls, 0 inspections, 23 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sri Johani Sdn. Bhd." is on file.

What these totals cover: FDA records filed under the name "Sri Johani Sdn. Bhd." and its spelling variant "Sri Johani Sdn. Bhd".

Latest 510(k)
Dec 3, 1999

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) clearances23Nov 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

23 510(k) clearances from Mar 29, 1989 to Dec 3, 1999. Showing the 20 most recent. View all 23 510(k) clearances

K-NumberDeviceDate
K993454POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)Dec 3, 1999
K993457POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]Dec 2, 1999
K993458POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)Nov 10, 1999
K981039POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)Apr 21, 1998
K980038POWDERFREE GREEN LATEX EXAMINATION GLOVESFeb 9, 1998
K980037POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)Feb 9, 1998
K980039POWDERED GREEN LATEX EXAMINATION GLOVESFeb 9, 1998
K974886POWDERED GREEN NITRILE EXAMINATION GLOVESJan 30, 1998
K974887POWDERFREE GREEN NITRILE EXAMINATION GLOVESJan 29, 1998
K974183POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)Dec 18, 1997
K974185POLYMER NITRILE EXAMINATION GLOVESDec 18, 1997
K974184HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)Dec 18, 1997
K973904POLYMER LATEX EXAMINATION GLOVESDec 17, 1997
K973903POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)Dec 17, 1997
K974182POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)Dec 17, 1997
K973801HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)Nov 21, 1997
K973815HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)Nov 21, 1997
K973058PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)Nov 7, 1997
K973059PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)Nov 7, 1997
K945247POWDERFREE LATEX EXAMINATION GLOVEJan 2, 1995

Sri Johani Sdn. Bhd. and the FDA: common questions

Has Sri Johani Sdn. Bhd. received an FDA warning letter?

No FDA warning letter addressed to the name "Sri Johani 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 Sri Johani Sdn. Bhd. received an FDA Form 483?

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

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