The following data is part of a premarket notification filed by Multisafe Sdn Bhd with the FDA for Multisafe Powder Free Nitrile Gloves, Non Sterile (blue).
| Device ID | K001619 |
| 510k Number | K001619 |
| Device Name: | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 Bidor, Perak, MY 35500 |
| Contact | Abd. Hadi Bin Husin |
| Correspondent | Abd. Hadi Bin Husin MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 Bidor, Perak, MY 35500 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-25 |
| Decision Date | 2000-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D89260705514240 | K001619 | 000 |
| 10850050195136 | K001619 | 000 |
| 10850050195129 | K001619 | 000 |
| 10850050195112 | K001619 | 000 |
| 10850050195105 | K001619 | 000 |
| 10850050195099 | K001619 | 000 |
| 10850050195082 | K001619 | 000 |
| 10850050195075 | K001619 | 000 |
| 10850050195068 | K001619 | 000 |
| 10850050195051 | K001619 | 000 |
| 10850050195044 | K001619 | 000 |
| 10850050195037 | K001619 | 000 |
| 10850050195020 | K001619 | 000 |
| 10850050195013 | K001619 | 000 |
| 20889813060128 | K001619 | 000 |
| 20889813060111 | K001619 | 000 |
| 20889813060104 | K001619 | 000 |
| 20889813060098 | K001619 | 000 |
| 10850050195143 | K001619 | 000 |
| 10850050195150 | K001619 | 000 |
| D773430200L1 | K001619 | 000 |
| D89260705514230 | K001619 | 000 |
| D89260705514220 | K001619 | 000 |
| D89260705514210 | K001619 | 000 |
| D89260705514200 | K001619 | 000 |
| D773430N300XS1 | K001619 | 000 |
| D773430N300XL1 | K001619 | 000 |
| D773430N300S1 | K001619 | 000 |
| D773430N300M1 | K001619 | 000 |
| D773430N300L1 | K001619 | 000 |
| D773430300521 | K001619 | 000 |
| D773430300421 | K001619 | 000 |
| D773430300321 | K001619 | 000 |
| D773430300221 | K001619 | 000 |
| D773430200XS1 | K001619 | 000 |
| D773430200XL1 | K001619 | 000 |
| D773430200S1 | K001619 | 000 |
| D773430200M1 | K001619 | 000 |
| 20889813060081 | K001619 | 000 |