(152 days)
A powder-free 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.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Nitrile Medical Examination Glove is a non-sterile, single-use, disposable glove intended for medical purposes to be worn on the hands of examiners to prevent contamination between an examiner and the patient. The gloves are made of nitrile butadiene rubber and are white-colored and powder-free. The gloves are offered in one version in a range of sizes: x-small, small, medium, large, and x-large.
The provided text describes the acceptance criteria and performance testing for a Nitrile Patient Examination Glove, specifically regarding its resistance to chemotherapy drugs and Fentanyl Citrate, as well as general safety and physical properties. It does not describe an AI medical device, therefore, many of the requested fields are not applicable.
Here's the breakdown based on the provided text:
Key Takeaway: This document is a 510(k) submission for a medical glove, demonstrating substantial equivalence to a predicate device, primarily through performance testing against established ASTM and ISO standards for physical properties, biocompatibility, and chemical permeation. It does not involve an AI algorithm or human-in-the-loop studies.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-10 | Irritation | Not a skin irritant | The subject device is non-irritating |
| ISO 10993-10 | Skin Sensitivity | Not a skin sensitizer | The subject device is non-sensitizing |
| ISO 10993-5 | Cytotoxicity | No cytotoxic reactivity | Failed (Exhibits severe cytotoxicity reactivity at 100%) |
| ISO 10993-11 | Acute Systemic Toxicity | No systemic reactivity | Pass (No systemic toxicity concern) |
| ASTM D6978 | Permeation of Chemotherapy Drugs | ≥240 minutes breakthrough time (for most drugs) | Pass (>240 minutes for most drugs, 33.3 for Carmustine, 66.2 for Thiotepa) |
| ASTM D6978 | Permeation of Fentanyl | ≥240 minutes breakthrough time | Pass (>240 minutes) |
| ASTM D6124 | Powder Residue | 2 mg/glove maximum | Pass |
| ASTM D5151 | Pinhole Test | Free from holes, AQL 1.5 | Pass |
| ASTM D6319 | Physical Properties (Before aging) | Tensile strength: Min. 14 MPa; Elongation: Min. 500% | Pass |
| ASTM D6319 | Physical Properties (After aging) | Tensile strength: Min. 14 MPa; Elongation: Min. 400% | Pass |
| Specific Chemotherapy Drugs | Minimum Breakthrough Detection Time (Minutes) (for those < 240 mins) | ||
| Carmustine (BCNU), 3.3 mg/ml | N/A (Actual performance listed here) | 33.3 (Warning: low permeation time) | |
| Thiotepa, 10.0 mg/ml | N/A (Actual performance listed here) | 66.2 (Warning: low permeation time) |
Note: The document explicitly states "Please note the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/ml) 33.3 minutes Thiotepa (10.0mg/ml) 66.2 minutes. Warning: Do not use these gloves with Carmustine or Thiotepa." This suggests that while a general ">=240 minutes" might be an overall expectation, these specific drugs fall below that, but are disclosed with warnings, indicating that the device still "passes" within the context of defined usage and limitations.
2. Sample sizes used for the test set and the data provenance
The document describes material testing, not a dataset in the typical sense for AI. No specific "sample sizes" for a "test set" of patient data are applicable or mentioned. The testing is performed on samples of the manufactured gloves themselves according to standard test methods (ASTM, ISO).
- Data Provenance: Not applicable. These are laboratory test results from the manufacturer's product, not patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical glove, and its performance is evaluated against physical and chemical permeation standards (ASTM, ISO), not expert interpretation of medical images or clinical data. There is no concept of "ground truth" established by experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiology reads). This involves objective laboratory testing against pre-defined physical and chemical resistance criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device or a diagnostic device involving human readers or interpretation of medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the validated and established laboratory test methods and standards (ASTM D6978, ISO 10993, etc.). For example:
- Permeation of chemotherapy drugs: Measured breakthrough time.
- Physical properties: Measured tensile strength, elongation.
- Biocompatibility: Measured biological reactions (irritation, sensitization, cytotoxicity, systemic toxicity) in accordance with ISO standards.
8. The sample size for the training set
Not applicable. This is a medical glove, not an AI model. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set for an AI model, there is no ground truth establishment for it.
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August 10, 2021
American Performance Polymers, LLC % Natalie Vollrath Sr. Regulatory Consultant MEDIcept, Inc. 200 Homer Avenue Ashland, Massachusetts 01721
Re: K210730
Trade/Device Name: Nitrile Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: Jun 23, 2021 Received: Jun 24, 2021
Dear Natalie Vollrath:
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.
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
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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 (OS) 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 Clarence W. Murray III, Ph.D. 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
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Indications for Use
510(k) Number (if known) K210730
Device Name Nitrile Patient Examination Glove
Indications for Use (Describe)
A powder-free 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.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min) |
|---|---|
| Carmustine (BCNU), 3.3 mg/ml | 33.3 |
| Cisplatin, 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan). 20.0 mg/ml | > 240 |
| Cytarabine Hydrochloride, 100 mg/ml | > 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| Daunorubicin, 5 mg/ml | > 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25.0 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| Thiotepa, 10.0 mg/ml | 66.2 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Fentanyl Citrate, 100mcg/2mL | > 240 |
Please note the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/ml) 33.3 minutes Thiotepa (10.0mg/ml) 66.2 minutes
Warning: Do not use these gloves with Carmustine or Thiotepa
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
CONTINUE ON A SEPARA
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510(k) Summary
(per 21 CFR 807.92)
1.0 Submitter/510(k) Holder
American Performance Polymers, LLC 23 Gould Street Colebrook, NH 03576
Contact Person: Natalie Vollrath Sr. Requlatory Consultant MEDIcept, Inc. (916) 695-5190 nvollrath@medicept.com
Date Prepared: August 5, 2021
2.0 Device Name
| Proprietary Name: | Pilgrim Nitrile Medical Examination Glove |
|---|---|
| Common Name: | Powder-Free Nitrile Patient Examination Glove |
| Classification Name: | Polymer Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA, LZC, OPJ, QDO |
| Classification Panel: | General Hospital |
| Device Classification: | Class I, reserved |
3.0 Predicate Device
K192954 - Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (21CFR 880.6250, Product Code: LZA, LZC, QDO)
4.0 Device Description
The Nitrile Medical Examination Glove is a non-sterile, single-use, disposable glove intended for medical purposes to be worn on the hands of examiners to prevent contamination between an examiner and the patient. The gloves are made of nitrile butadiene rubber and are white-colored and powder-free. The gloves are offered in one version in a range of sizes: x-small, small, medium, large, and x-large.
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5.0 Intended Use/Indications for Use
A powder-free 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.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time(Minutes) |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml | 33.3 |
| Cisplatin 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | > 240 |
| Cytarabine 100 mg/ml | > 240 |
| Dacarbazine 10.0 mg/ml | > 240 |
| Daunorubicin HCI 5.0 mg/ml | > 240 |
| Doxorubicin HCI 2.0 mg/ml | > 240 |
| Etoposide 20.0 mg/ml | > 240 |
| Fluorouracil 50.0 mg/ml | > 240 |
| Ifosfamide 50.0 mg/ml | > 240 |
| Methotrexate 25.0 mg/ml | > 240 |
| Mitoxantrone 2mg/ml | > 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | > 240 |
| Thiotepa 10.0 mg/ml | 66.2 |
| Vincristine Sulfate 1.0 mg/ml | > 240 |
| Fentanyl Citrate 100mcg/2mL | > 240 |
|---|---|
| ----------------------------- | ------- |
Please note the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/ml) 33.3 minutes Thiotepa (10.0mg/ml) 66.2 minutes
Warning: Do not use these gloves with Carmustine or Thiotepa
6.0 Technological Characteristics and Substantial Equivalence
The Nitrile Patient Examination Gloves are summarized within the the following table comparing technological characteristics to the ASTM of the subject gloves to the predicate device.
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| Proposed DeviceK210730 | Predicate DeviceK192954 | Comparison | |
|---|---|---|---|
| Device Classification Name | Patient Examination Glove | Patient Examination Glove | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Similar |
| Intended Use | The Nitrile Patient Examination Glove, non-sterile and powder-free is a disposable device intended for medical purposed that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various types of chemotherapy drugs and Fentanyl Citrate | The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs and Fentanyl Citrate | Similar |
| Prescription v. OTC | OTC | OTC | Same |
| Dimension | Length-XS >229mm, S, M, L, XL >239mm Thickness palm and finger- >0.075mm | Length-Min 240mm Thickness palm and finger- Min 0.05mm | Similar |
| ASTM D6319 - 10 | Palm width:XS 70 ± 10mmS 80 ± 10mmM 95 ± 10mmL 110 ± 10mmXL 120 ± 10mm | ------ | Different |
| Proposed DeviceK210730 | Predicate DeviceK192954 | Comparison | |
| Physical PropertiesASTM D6319 - 10 | Meets | Meets | Same |
| Thickness - Finger, PalmASTM D6319 - 10 | Meets | Meets | Same |
| Powder ContentASTM - D6124 - 06(≤2 mg/glove) | Meets | Meets | Same |
| Chemotherapy Drug Permeation Test ASTM D6978-05 | |||
| Chemotherapy Drugwith Concentration: | Minimum Breakthrough Detection Time(Min.) | ||
| Cisplatin 1.0 mg/ml | >240 | >240 | Same |
| Cyclophosphamide(Cytoxan) 20.0 mg/ml | >240 | >240 | Same |
| Cytarabine 100 mg/ml | >240 | --- | Different |
| Dacarbazine 10.0 mg/ml | >240 | >240 | Same |
| Daunorubicin HCI 5.0mg/ml | >240 | --- | Different |
| Doxorubicin HCI 2.0mg/ml | >240 | >240 | Same |
| Etoposide 20.0 mg/ml | >240 | >240 | Same |
| Fluorouracil 50.0 mg/ml | >240 | >240 | Same |
| Ifosfamide 50.0 mg/ml | >240 | >240 | Same |
| Methotrexate 25.0 mg/ml | >240 | --- | Different |
| Mitoxantrone 2mg/ml | >240 | >240 | Same |
| Paclitaxel (Taxol) 6.0mg/ml | >240 | >240 | Same |
| Vincristine Sulfate 1.0mg/ml | >240 | >240 | Same |
| Proposed Device | Predicate Device | Comparison | |
| K210730 | K192954 | ||
| Carmustine (BCNU) 3.3 mg/ml | 33.3 | 18.2 | Similar |
| Thiotepa 10.0 mg/ml | 66.2 | 57.3 | Similar |
| Warning Statement | Please note that the following drugs have low permeation timesCarmustine (BCNU): 33.3 minutes andThiotepa: 66.2 minutesWarning: Do not use with Carmustine orThiotepa | * WARNINGPlease note that the following drugs have extremely low permeation timesCarmustine (BCNU): 18.2 minutes andThiotepa: 57.3 minutes | Similar |
| Fentanyl Citrate Permeation Test ASTM D6978-05 | |||
| With Concentration: | Minimum Breakthrough Detection Time(Min.) | ||
| Fentanyl Citrate100mcg/2mL | >240 | >240 | Same |
| Biocompatibility:IrritationISO 10993-10 | PassesUnder the conditions of the study, thesubject device is non-irritating | PassesUnder the conditions of the study, thesubject device is non-irritating | Same |
| Biocompatibility:Skin SensitizationISO 10993-10 | PassesUnder the conditions of the study, thesubject device is non-sensitizing | PassesUnder the conditions of the study, thesubject device is non-sensitizing | Same |
| Proposed DeviceK210730 | Predicate DeviceK192954 | Comparison | |
| Biocompatibility:CytotoxicityISO 10993-5 | Exhibits severecytotoxicity reactivityat 100% | Exhibits severecytotoxicity reactivityat 100%, and 66%extractconcentrations andno cytotoxicityreactivity at 44%,30%, 20% and 15%extractconcentrations underthe condition of thistest | Similar |
| Biocompatibility:Acute Systemic ToxicityISO 10993-11 | PassesAdditional acutesystemic toxicitytesting resultsshowed no systemictoxicity concern | PassesUnder the conditionsof the study, thesubject showed noadverse biologicalreaction | Similar |
| Pinhole Test | Passes | Passes | Same |
| Material | Nitrile | Nitrile | Same |
| Color | White | Blue | Different |
| Size | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Sterile v. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single-Use v. Reusable | Single-Use | Single-Use | Same |
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The Chemotherapy claim is similar to the predicate, which has a glove thickness that complies with the ASTM Standards. Compared with the predicate, the subject device was tested with additional chemotherapy drugs.
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7.0 Performance Testing
Non-clinical testing was performed to demonstrate that the proposed device meets requirements.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10 | Irritation | Not a skin irritant | The subject device isnon-irritating |
| ISO 10993-10 | Skin Sensitivity | Not a skin sensitizer | The subject device isnon-sensitizing |
| ISO 10993-5 | Cytotoxicity | No cytotoxic reactivity | Failed |
| ISO 10993-11 | Acute SystemicToxicity | No systemic reactivity | Pass |
| ASTM D6978 | Permeation ofChemotherapy Drugs | ≥240 minutesbreakthrough time | Pass |
| ASTM D6978 | Permeation ofFentanyl | ≥240 minutesbreakthrough time | Pass |
| ASTM D6124 | Powder Residue | 2 mg/glove maximum | Pass |
| ASTM D5151 | Pinhole Test | Free from holes, AQL1.5 | Pass |
| ASTM D6319 | Physical Properties | Before agingTensile strength:Min. 14 MPaElongation: Min.500%After agingTensile strength: Min.14 MPaElongation: Min.400% | Pass |
8.0 Conclusion
Results from non-clinical performance testing to applicable standards demonstrate that the proposed Pilgrim Gloves are as safe and effective as the legally marketed predicate gloves.
§ 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.