Sri Johani Sdn. Bhd.
Malaysia, MY
Sri Johani Sdn. Bhd. appears in FDA device records in Malaysia, MY. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Sri Johani Sdn. Bhd. between 1989 and 1999. The busiest year on record is 1997, with 10. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 2 |
| 1995 | 1 |
| 1997 | 10 |
| 1998 | 6 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993454 | POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K993457 | POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] | LYY | Substantially Equivalent | |
| K993458 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) | LYY | Substantially Equivalent | |
| K981039 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | LZA | Substantially Equivalent | |
| K980039 | POWDERED GREEN LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K980038 | POWDERFREE GREEN LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K980037 | POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) | LYY | Substantially Equivalent | |
| K974886 | POWDERED GREEN NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K974887 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K974185 | POLYMER NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K974184 | HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) | LYY | Substantially Equivalent | |
| K974183 | POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) | LZA | Substantially Equivalent | |
| K974182 | POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) | LZA | Substantially Equivalent | |
| K973904 | POLYMER LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K973903 | POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) | LZA | Substantially Equivalent | |
| K973815 | HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR) | LYY | Substantially Equivalent | |
| K973801 | HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) | LYY | Substantially Equivalent | |
| K973059 | PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) | LZA | Substantially Equivalent | |
| K973058 | PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) | LZA | Substantially Equivalent | |
| K945247 | POWDERFREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K900869 | NON-STERILE LATEX PROCEDURE GLOVE | LYY | Substantially Equivalent | |
| K900868 | STERILE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K891378 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially 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
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