Company ยท MY
Sri Johani Sdn. Bhd.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1999. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 3, 1999 | K993454 | POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) Sri Johani Sdn. Bhd., MY | LYY |
| Dec 2, 1999 | K993457 | POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] Sri Johani Sdn. Bhd., MY | LYY |
| Nov 10, 1999 | K993458 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) Sri Johani Sdn. Bhd., MY | LYY |
| Apr 21, 1998 | K981039 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) Sri Johani Sdn. Bhd., MY | LZA |
| Feb 9, 1998 | K980039 | POWDERED GREEN LATEX EXAMINATION GLOVES Sri Johani Sdn. Bhd., MY | LYY |
| Feb 9, 1998 | K980038 | POWDERFREE GREEN LATEX EXAMINATION GLOVES Sri Johani Sdn. Bhd., MY | LYY |
| Feb 9, 1998 | K980037 | POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) Sri Johani Sdn. Bhd., MY | LYY |
| Jan 30, 1998 | K974886 | POWDERED GREEN NITRILE EXAMINATION GLOVES Sri Johani Sdn. Bhd., MY | LZA |
| Jan 29, 1998 | K974887 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES Sri Johani Sdn. Bhd., MY | LZA |
| Dec 18, 1997 | K974185 | POLYMER NITRILE EXAMINATION GLOVES Sri Johani Sdn. Bhd., MY | LZA |
| Dec 18, 1997 | K974184 | HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd., MY | LYY |
| Dec 18, 1997 | K974183 | POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd., MY | LZA |
| Dec 17, 1997 | K974182 | POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd., MY | LZA |
| Dec 17, 1997 | K973904 | POLYMER LATEX EXAMINATION GLOVES Sri Johani Sdn. Bhd., MY | LYY |
| Dec 17, 1997 | K973903 | POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd., MY | LZA |
| Nov 21, 1997 | K973815 | HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd., MY | LYY |
| Nov 21, 1997 | K973801 | HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd., MY | LYY |
| Nov 7, 1997 | K973059 | PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) Sri Johani Sdn. Bhd., MY | LZA |
| Nov 7, 1997 | K973058 | PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) Sri Johani Sdn. Bhd., MY | LZA |
| Jan 2, 1995 | K945247 | POWDERFREE LATEX EXAMINATION GLOVE Sri Johani Sdn. Bhd., MY | LYY |
| Mar 9, 1990 | K900869 | NON-STERILE LATEX PROCEDURE GLOVE Sri Johani Sdn. Bhd. | LYY |
| Mar 9, 1990 | K900868 | STERILE LATEX EXAMINATION GLOVE Sri Johani Sdn. Bhd. | LYY |
| Mar 29, 1989 | K891378 | PATIENT EXAMINATION GLOVES (LATEX) Sri Johani Sdn. Bhd., MY | LYY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||