510(k) K090568
- Device
- MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
- Applicant
- MEDLINE INDUSTRIES, INC.
- 510(k) number
- K090568
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-02
- Date received
- 2009-03-03
- Regulation
- 880.6250
- Classification name
- Polymer Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATT CLAUSEN
- Address
- One Medline Pl. Mundelein IL US 60060 60060
FDA Registration Numbers#
- 3009229300
- 3004995451
- 3010621964
- 1000254914
- 3003851058
- 3034669683
- 3004513970
- 8040614
- 3038356900
- 3002661124
- 3005022483
- 3021233711
- 3024712919
- 1221744
- 3010864832
- 3013514660
- 3005568780
- 3021015522
- 3021394840
- 3015412466
- 3015142965
- 8041108
- 3012050423
- 3020831613
- 3016866909
- 3030671502
- 3035455506
- 3031180726
- 3005024009
- 3021206556
- 3005558160
- 9610406
- 2939935
- 3013565389
- 1054241
- 2938651
- 3038592309
- 3023862
- 2026990
- 2954902
- 3024999439
- 3003887292
- 3011238790
- 3028652705
- 1937310
- 3010148335
- 9681247
- 3012421607
- 1250045
- 3027601983
- 3018108902
- 3011658061
- 3006534695
- 9613998
- 3009211686
- 3007838093
- 3014269027
- 3030214028
- 2087418
- 3004111573
- 1319302
- 3023228837
- 3008076203
- 9617453
- 3019944216
- 3021915797
- 3017929385
- 3009964047
- 3003199637
- 3008489813
- 3005885230
- 3003895865
- 3011050560
- 3021206557
- 3021286079
- 1000266564
- 2086655
- 3017509841
- 3015173212
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | 2026-06-24 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | 2026-06-03 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | 2026-01-13 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | 2025-10-17 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | 2025-08-27 |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. | 2025-08-18 |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Hartalega NGC Sdn. Bhd. | 2025-07-30 |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Basic Medical Technology, Inc. | 2025-07-09 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases