(233 days)
Not Found
Not Found
No
The device is a physical examination glove and the description focuses on its material properties and resistance to chemicals, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device description indicates it is a glove worn to prevent contamination, which is a barrier function, not a therapeutic one. It does not treat or cure any condition.
No
The device, Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly identifies the device as "Blue Non Sterile Powder Free Nitrile Examination Gloves," which are physical hardware (gloves) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a disposable device worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier device for personal protection and infection control.
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
- Device Description: The description confirms it's a glove.
- Performance Studies: The performance studies focus on the glove's barrier properties (resistance to chemotherapy drugs and fentanyl permeation), not on analyzing biological samples.
Therefore, this device falls under the category of a medical device for personal protection and infection control, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA, ODO
Device Description
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatits and Fentanyl Permeation Resistance Claim
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
July 4, 2019
Central Medicare Sdn. Bhd. Muhammad Rahman Product Assistant Manager PT 2609-2620, BT 8, Jalan Changkat Jong Teluk Intan, 36000 My
Re: K183149
Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA, ODO Dated: May 30, 2019 Received: June 3, 2019
Dear Muhammad Rahman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183149
Device Name
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatits and Fentanyl Permeation Resistance Claim
Indications for Use (Describe)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug | Concentrate(mg/ml) | Minimum Breakthrough Detection Time (minutes) |
|---|---|---|
| Bleomycin Sulfate | 15 | >240 |
| Busulfan | 6 | >240 |
| Carboplatin | 10 | >240 |
| *Carmustine | 3.3 | 12.4 |
| Cisplatin | 1 | >240 |
| Chloroquine | 50 | >240 |
| Cyclophosphamide | 20 | >240 |
| Cyclosporin | 100 | >240 |
| Cytarabine HCI | 100 | >240 |
| Dacarbazine | 10 | >240 |
| Daunorubicin HCI | 5 | >240 |
| Docetaxel | 10 | >240 |
| Doxorubicin Hydrochloride | 2 | >240 |
| Epirubicin (Ellence) | 2 | >240 |
| Etoposide | 20 | >240 |
| Fludarabine | 25 | >240 |
| Fluorouracil | 50 | >240 |
| Gemcitabine | 38 | >240 |
| Idarubicin | 1 | >240 |
| Ifosfamide | 50 | >240 |
| Irinotecan | 20 | >240 |
| Mechlorethamine HCI | 1 | >240 |
| Melphalan | 5 | >240 |
| Methotrexate | 25 | >240 |
| Mitomycin | 0.5 | >240 |
| Mitoxantrone | 2 | >240 |
| Oxaliplatin | 5 | >240 |
| Paclitaxel | 6 | >240 |
| Paraplatin | 10 | >240 |
| Retrovir | 10 | >240 |
3
| Rituximab | 10 | >240 |
|---|---|---|
| *Thiotepa | 10 | 24.4 |
| Topotecane | 1 | >240 |
| Trisonex | 1 | >240 |
| Velcade | 1 | >240 |
| Vincristine Sulfate | 1 | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
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