(261 days)
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No
The device is a physical examination glove and the description focuses on its material properties and resistance to various substances, not on any computational or analytical capabilities.
No
Explanation: The device is an examination glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is described as examination gloves intended to prevent contamination, not to diagnose medical conditions.
No
The device is a physical glove, not a software program. The description focuses on material properties and resistance to chemicals, which are hardware characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostic products are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. They are used to examine specimens taken from the human body, such as blood, urine, or tissue.
- Intended Use of the Device: The intended use of the Blue Non Sterile Powder Free Nitrile Examination Gloves is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner."
- Function of the Device: The device acts as a barrier to protect the examiner from potential contaminants and to prevent the examiner from contaminating the patient.
- Lack of Diagnostic Function: The gloves do not perform any diagnostic test or analysis on a specimen from the human body. Their function is purely protective and preventative.
While the gloves are tested for resistance to various substances, including chemotherapy drugs, fentanyl, and gastric acid, this testing relates to their barrier properties and safety for the user, not to their use in diagnosing a condition.
N/A
Intended Use / Indications for Use
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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.
Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >>240 mins
Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HC1 5.0 mg/ml >>240 mins Bleomycin Sulfate 15.0 mg/ml >>240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml >>240 mins Chloroquine 50.0 mg/ml >>240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml >>240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml >> 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml >>240 mins Decitibine 5.0 mg/ml >>240 mins Docetaxel 10.0 mg/ml >>240 mins Doxorubicin Hydrochloride 2.0 mg/ml >>240 mins Epirubicin (Ellence) 2.0 mg/ml >> 240 mins Etoposide (Toposar) 20.0 mg/ml >>240 mins Fludarabine 25.0 mg/ml >>240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml >> 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml >>240 mins Irinotecan 20.0 mg/ml >>240 mins Mechlorethamine HCl 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml >>240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml >>240 mins Mitomycin C 0.5 mg/ml >>240 mins
Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml >>240 mins Paraplatin 10.0 mg/ml >>240 mins Pemetrexed 25.0 mg/ml >>240 mins Pertuzumab 30.0 mg/ml >>240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml >>240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCl 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml >>240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml >> 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml >>240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml >>240 mins Zoledronic Acid 0.8 mg/ml > 240 mins
CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine.
WARNING: Do not use with Carmustine and Thiotepa.
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. Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA, QDO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 22, 2021
Central Medicare Sdn Bhd Muhammad Rahman Product Assistant Manager PT 2609-2620, Batu 8. Jalan Changkat Jong. Teluk Intan, Perak 36000 Malaysia
Re: K211022
Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, LZA, QDO Dated: November 12, 2021 Received: November 26, 2021
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 medical devices and radiation-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.
Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211022
Device Name
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Castric Acid and Fentanyl Permeation Resistance Claims
Indications for Use (Describe)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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.
Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >>240 mins
Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HC1 5.0 mg/ml >>240 mins Bleomycin Sulfate 15.0 mg/ml >>240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml >>240 mins Chloroquine 50.0 mg/ml >>240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml >>240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml >> 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml >>240 mins Decitibine 5.0 mg/ml >>240 mins Docetaxel 10.0 mg/ml >>240 mins Doxorubicin Hydrochloride 2.0 mg/ml >>240 mins Epirubicin (Ellence) 2.0 mg/ml >> 240 mins Etoposide (Toposar) 20.0 mg/ml >>240 mins Fludarabine 25.0 mg/ml >>240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml >> 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml >>240 mins Irinotecan 20.0 mg/ml >>240 mins Mechlorethamine HCl 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml >>240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml >>240 mins Mitomycin C 0.5 mg/ml >>240 mins
3
Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml >>240 mins Paraplatin 10.0 mg/ml >>240 mins Pemetrexed 25.0 mg/ml >>240 mins Pertuzumab 30.0 mg/ml >>240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml >>240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCl 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml >>240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml >> 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml >>240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml >>240 mins Zoledronic Acid 0.8 mg/ml > 240 mins
CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine.
WARNING: Do not use with Carmustine and Thiotepa.
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. Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, 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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