(105 days)
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The tested chemotherapy drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min
Carboplatin (10.0 mg/ml 10,000 ppm) >240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2
Cisplatin (1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min
Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Idarubicin (1.0 mg/ml 1.000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min
Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 13.1
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
The tested non-chemotherapy drugs are:
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
MESNA (100.0 mg/mL 100,000 ppm) >240 min
Trisenox (1.0 mg/ml 1,000 ppm) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)". It outlines the device's characteristics, indications for use, and a comparison to a predicate device, focusing on non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance.
The document provides multiple tables summarizing the performance and comparison of the proposed device to predicate devices. The primary table serving this purpose is "Table 3 Performance comparison" and the table that includes "Test Method," "Purpose," "Acceptance Criteria," and "Results" on Page 13.
| Test/Characteristic | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Physical Properties (ASTM D6319-19) | ||
| Before Aging | Tensile strength: ≥14 MPa, min; Ultimate elongation: 500%, min | Tensile strength: 14MPa, min; Ultimate elongation: 500%, min (Implied "Pass" based on overall result) |
| After Aging | Tensile strength: ≥14 MPa, min; Ultimate elongation: 400%, min | Tensile strength: 14MPa, min; Ultimate elongation: 400%, min (Implied "Pass" based on overall result) |
| Freedom from Holes (ASTM D5151-19) | No leakage at sampling level of G-1, AQL 2.5 | Pass |
| Residual Powder (ASTM D6124-06 (2022)) | <2mg per glove | Pass |
| Dimensions (ASTM D6319-19) | Length: 240mm min | Pass |
| Palm Width (XS) | 70±10mm | Pass (70±10) |
| Palm Width (S) | 80±10mm | Pass (80±10) |
| Palm Width (M) | 95±10mm | Pass (95±10) |
| Palm Width (L) | 110±10mm | Pass (110±10) |
| Palm Width (XL) | 120±10mm | Pass (120±10) |
| Palm Width (XXL) | 130±10mm | Pass (130±10) |
| Thickness (Finger) | ≥0.05 mm | Pass |
| Thickness (Palm) | ≥0.05 mm | Pass |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) & Fentanyl | Refer to Table 4 for specific breakthrough detection times for each drug. The primary acceptance criteria for most drugs is >240 minutes, with specific, lower times for Carmustine (13.2 min) and Thiotepa (13.1 min). | The reported results in Table 4 (pages 10-11) match the acceptance criteria for each drug, indicating "Pass" or "Same". For Carmustine (13.2 min) and Thiotepa (13.1 min), the results are noted as "Similar" to the predicate, with explicit warnings not to use with these drugs due to low permeation times. |
| Biocompatibility | Irritation (ISO 10993-23): Not an irritant. | Under the conditions of the study, not an irritant. |
| Sensitization (ISO 10993-10): Not a sensitizer. | Under the conditions of the study, not a sensitizer. | |
| Acute Systemic Toxicity (ISO 10993-11): Device extract does not induce acute systemic toxicity reaction. | Under the conditions of the study, the device extract does not induce acute systemic toxicity response. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
The document does not specify the exact sample sizes used for each physical or chemical test. It references ASTM standards, which would typically define sampling plans. For instance, for Freedom from Holes, it mentions "sampling level of G-1, AQL 2.5," which refers to specific statistical sampling plans within ASTM D5151, but not the explicit number of gloves tested.
The data provenance is from non-clinical tests conducted to relevant ASTM and ISO standards. The Applicant, Shandong Xingyu Gloves Co., Ltd., is located in China, suggesting the tests were likely conducted there or by affiliated labs. The testing appears to be prospective as it was done specifically to evaluate the performance of this new device for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience).
This document describes a device (gloves) and its performance under various physical and chemical stress tests, not imaging or diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the medical image interpretation sense (e.g., radiologists) is not applicable here. The "ground truth" for the performance claims (e.g., tensile strength, breakthrough time) is established by adherence to the specified and validated ASTM and ISO laboratory test methods and their defined measurement protocols. The experts involved would be the qualified laboratory technicians and chemists performing these standardized tests. Their qualifications are implicitly that they are capable of performing these standardized tests correctly.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set.
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving subjective human interpretation of data (e.g., medical images), where disagreements between readers need to be resolved by a third or fourth expert. Since this document describes non-clinical, objective laboratory testing of physical and chemical properties, an adjudication method as typically understood in a multi-reader clinical study is not applicable. The results are directly measured by instruments and adherence to test protocols.
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.
No, an MRMC comparative effectiveness study was not conducted. This is a 510(k) submission for medical gloves, based on non-clinical performance testing against established standards, not a diagnostic AI device requiring human reader interaction studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The "ground truth" for this device's performance claims is based on objective measurements obtained through standardized laboratory test methods (ASTM and ISO standards). For example:
- Physical properties (tensile strength, elongation): Measured in a lab according to ASTM D6319.
- Freedom from holes: Tested by inflation or water leak methods per ASTM D5151.
- Residual powder: Measured gravimetrically per ASTM D6124.
- Permeation by chemotherapy drugs/Fentanyl: Measured chromatographically by detecting breakthrough according to ASTM D6978.
- Biocompatibility: Evaluated in in vitro or in vivo models for specific biological endpoints (irritation, sensitization, systemic toxicity) following ISO 10993 standards.
The ground truth is therefore defined by the quantitative and qualitative results of these standardized, validated test procedures.
8. The sample size for the training set.
There is no training set mentioned or implied because this is not an AI/machine learning device. The device's performance is demonstrated through standard laboratory testing, not by training a model on a dataset.
9. How the ground truth for the training set was established.
As there is no training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 1, 2024
Shandong Xingyu Gloves Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K233990
Trade/Device Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) 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: March 11, 2024 Received: March 11, 2024
Dear Ivy Wang:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Allan G
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control
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and Plastic and Reconstructive 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) K233990
Device Name
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
Indications for Use (Describe)
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The tested chemotherapy drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min
Carboplatin (10.0 mg/ml 10,000 ppm) >240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2
Cisplatin (1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min
Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Idarubicin (1.0 mg/ml 1.000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min
Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 13.1
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
The tested non-chemotherapy drugs are:
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
MESNA (100.0 mg/mL 100,000 ppm) >240 min
Trisenox (1.0 mg/ml 1,000 ppm) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.
Warning: Do Not Use with Carmustine, 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.
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510(K) Summary
K233990
(As required by 21 CFR 807.92)
Date prepared: 2024-04-01
A. Applicant:
Name: Shandong Xingyu Gloves Co., Ltd. Address: NO. 2158 Yaoqian Road, Economic Development Zone, Gaomi City, Shandong Province, China Contact: Ms. Carrie Lee Title: QA Manager Tel: 0086-536-2580359 Email: carrie@xingyugloves.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
B. Device:
Trade Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Common Name: Nitrile Patient Examination Gloves (Powder Free) Model: D5000 Size(s): XS, S, M, L, XL, XXL
Regulatory Information Classification Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA (Primary), LZC, OPJ, QDO Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
510K Number: K223903 Trade Name: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl Manufacturer: SEMPERIT INVESTMENTS ASIA PTE. LTD. Reference Device
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510K Number: K212735
Trade Name: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) Manufacturer: Xingyu Medical Tech Co., Ltd.
D. Indications for use of the device:
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The tested chemotherapy drugs are:
| Chemotherapy drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Bleomycin sulfate | (15.0 mg/ml 15,000 ppm) | >240 min |
| Carboplatin | (10.0 mg/ml 10,000 ppm) | >240 min |
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 13.2 |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | >240 min |
| Cyclophosphamide | (20.0 mg/mL 20,000 ppm) | >240 min |
| Cytarabine (Cytosine) | (100.0 mg/mL 100,000 ppm) | >240 min |
| Dacarbazine | (10.0 mg/mL 10,000 ppm) | >240 min |
| Doxorubicin HCL | (2.0 mg/mL 2,000 ppm) | >240 min |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | >240 min |
| Fluorouracil (5 Flu) | (50.0 mg/mL 50,000 ppm) | >240 min |
| Idarubicin | (1.0 mg/ml 1,000 ppm) | >240 min |
| Ifosfamide | (50.0 mg/mL 50,000 ppm) | >240 min |
| Mechlorethamine HCL | (1.0 mg/ml 1,000 ppm) | >240 min |
| Methotrexate | (25.0 mg/mL 25,000 ppm) | >240 min |
| Mitomycin C | (0.5 mg/mL 500 ppm) | >240 min |
| Mitoxantrone HCL | (2.0 mg/mL 2,000 ppm | >240 min |
| Paclitaxel | (6.0 mg/mL 6,000 ppm) | >240 min |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 13.1 |
| Vincristine Sulfate | (1.0 mg/mL 1,000 ppm | >240 min |
| The tested non-chemotherapy drugs are: | ||
| Fentanyl Citrate Injection | (100 mcg/2mL) | >240 min |
| MESNA | (100.0 mg/mL 100,000 ppm) | >240 min |
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
240 min
(1.0 mg/ml 1,000 ppm)
E. Device Description:
Trisenox
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.
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The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
F. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K233990 | K223903 | - |
| Product Name | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl | - |
| Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC, OPJ, QDO | Same |
| Classification | Class I | Class I | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for use | The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978.The tested chemotherapy drugs are:Chemotherapy drug ConcentrationMinimum Breakthrough Detection TimeBleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 minCarboplatin (10.0 mg/ml 10,000 ppm) > 240 minCarmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2Cisplatin (1.0 mg/mL 1,000 ppm) >240 minCyclophosphamide (20.0 mg/mL 20,000 ppm) >240 minCytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 minDacarbazine (10.0 mg/mL 10,000 ppm) >240 minDoxorubicin HCl (2.0 mg/mL 2,000 | This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner.The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutesCyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutesCytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutesDoxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough un | SimilarThe proposed device and the predicate device have same indications, only minor differences on different drugs and the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance |
| > 240 min | to 240 minutes | concerns. | |
| Etoposide (Toposar) (20.0 mg/mL20,000 ppm) > 240 min | Etoposide (20.0 mg/ml). Permeationtime: no breakthrough up to 240minutes | ||
| Fluorouracil (5 Flu) (50.0 mg/mL50,000 ppm) >240 min | Fluorouracil (50.0 mg/ml).Permeation time: no breakthrough upto 240 minutes | ||
| Idarubicin (1.0 mg/ml 1,000 ppm) >240 min | |||
| Ifosfamide (50.0 mg/mL 50,000 ppm)> 240 min | Ifosfamide (50.0 mg/ml). Permeationtime: no breakthrough up to 240minutes | ||
| Mechlorethamine HCL (1.0 mg/ml 1,000ppm) > 240 min | Methotrexate (25.0mg/ml). Permeation time: nobreakthrough up to 240 minutes | ||
| MESNA (100.0 mg/mL 100,000 ppm) >240 min | |||
| Methotrexate (25.0 mg/mL 25,000ppm) >240 min | Mitomycin C (0.5 mg/ml). Permeationtime: no breakthrough up to 240minutes | ||
| Mitomycin C (0.5 mg/mL 500 ppm) >240 min | |||
| Mitoxantrone HCL (2.0 mg/mL 2,000 ppm> 240 min | Mitoxantrone (2.0 mg/ml).Permeation time: no breakthrough upto 240 minutes | ||
| Paclitaxel (6.0 mg/mL 6,000 ppm) >240 min | Paclitaxel (Taxol) (6.0mg/ml). Permeation time: nobreakthrough up to 240 minutes | ||
| Thiotepa (10.0 mg/mL 10,000 ppm)13.1 | Thiotepa (10.0 mg/ml). Permeationtime: Thiotepa has extremely lowpermeation times of 13.6 minutes | ||
| Trisenox (1.0 mg/ml 1,000 ppm) > 240min | Vincristine Sulfate (1.0 mg/ml).Permeation time: no Breakthrough upto 240 minutes. | ||
| Vincristine Sulfate (1.0 mg/mL 1,000 ppm>240 min | |||
| Fentanyl Citrate Injection (100 mcg/2mL) >240 min | The tested Opioid is:Fentanyl Citrate Injection(100mcg/2mL). Permeation: nobreakthrough up to 240 minutes | ||
| Note: Carmustine and Thiotepa haveextremely low permeation times of 13.2and 13.1 minutes respectively. | Please note that the following drugshave extremely low permeation times:Carmustine: 14.7 minutesThiotepa: 13.6 minutesWarning: DO NOT USE WITHCARMUSTINE OR THIOTEPA | ||
| Powder free | Yes | Yes | Same |
| Designfeature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Singe use | Single use | Same |
| Labeling claim | Tested for Use with Chemotherapy Drugsand Fentanyl | Tested for Use with Chemotherapy Drugsand Fentanyl | Same |
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Table 2 Device dimension comparison
| Technological characteristics | ProposedDevice(K233990) | PredicateDevice(K223903) | Device | Result |
|---|---|---|---|---|
| Length | ||||
| XS, S | Minimum 240mm | Minimum 220mm | Different | |
| M, L, XL | Minimum 230mm | The length dimension of the | ||
| XXL | Not available | proposed device is not thesame with the predicatedevice, while both are meetthe criteria of the ASTMD6319 standard. | ||
| Palm width (size) (mm) | ||||
| XS | 70±10 | 70±10 | Same | |
| S | 80±10 | 80±10 | Same | |
| M | 95±10 | 95±10 | Same | |
| L | 110±10 | 110±10 | same | |
| XL | 120±10 | 120±10 | Same | |
| XXL | 130±10 | Not available | DifferentThe proposed device has onemore size (XXL) than thepredicate device, howeverthe dimension of theproposed device has beentested and complied with theASTM D6319-19. Thisdimension different will notraise any new safety orperformance concerns. | |
| Thickness (mm) | ||||
| Finger | ≥0.05 | ≥0.05 | Same | |
| Palm | ≥0.05 | ≥0.05 | Same |
Table 3 Performance comparison
| Item | Proposed device(K233990) | Predicate(K223903) | device | Result | |
|---|---|---|---|---|---|
| Physicalproperties | Before aging | Tensile strength | 14MPa, min | 14MPa, min | Same |
| Ultimate elongation | 500%, min | 500%, min | Same | ||
| After aging | Tensile strength | 14MPa, min | 14MPa, min | Same |
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| Ultimate elongation | 400%, min | 400%, min | Same | |
|---|---|---|---|---|
| Comply with ASTM D6319 | Comply with ASTM D6319 | Same | ||
| Freedom from holes | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Same | |
| Residual Powder | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same |
Table 4 Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drugs, non-chemotherapy drugs and fentanyl and Concentration | Minimum breakthrough detection time in minutes | Result | ||
|---|---|---|---|---|
| Proposed device (K233990) | Predicate device (K223903) | Reference device (K212735) | ||
| Bleomycin sulfate (15.0 mg/ml 15,000 ppm) | >240 | Not available | >240 | Same with reference device |
| Carboplatin (10.0 mg/ml 10,000 ppm) | >240 | Not available | >240 | Same with reference device |
| Carmustine (BCNU) (3.3mg/mL 3,300 ppm) | 13.2 | 14.7 | 47.9 | Similar |
| Cisplatin (1.0 mg/mL 1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide (20 mg/mL 20,000 ppm) | >240 | >240 | >240 | Same |
| Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) | >240 | >240 | >240 | Same |
| Dacarbazine (10 mg/mL 10,000 ppm) | >240 | >240 | >240 | Same |
| Doxorubicin HCL (2.0 mg/mL 2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) | >240 | >240 | >240 | Same |
| Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) | >240 | >240 | >240 | Same |
| Idarubicin (1.0 mg/ml 1,000 ppm) | >240 | Not available | >240 | Same with reference device |
| Ifosfamide (50.0 mg/mL 50,000 ppm) | >240 | >240 | >240 | Same |
| Mechlorethamine HCI | >240 | Not available | >240 | Same with |
{11}------------------------------------------------
| (1.0 mg/ml 1,000 ppm) | reference | |||
|---|---|---|---|---|
| device | ||||
| MESNA (100.0 mg/mL 100,000 ppm) | >240 | Not available | >240 | Same withreferencedevice |
| Methotrexate (25.0 mg/mL 25,000 ppm) | >240 | >240 | >240 | Same |
| Mitomycin C (0.5 mg/mL 500 ppm) | >240 | >240 | >240 | Same |
| Mitoxantrone HCL (2.0 mg/mL 2,000 ppm | >240 | >240 | >240 | Same |
| Paclitaxel (6.0 mg/mL 6,000 ppm) | >240 | >240 | >240 | Same |
| Thiotepa (10.0 mg/mL 10,000 ppm) | 13.1 | 13.6 | >240 | Similar |
| Trisenox (1.0 mg/ml 1,000 ppm) | >240 | Not available | >240 | Same withreferencedevice |
| Vincristine Sulfate (1.0 mg/mL 1,000 ppm | >240 | >240 | >240 | Same |
| Fentanyl Citrate Injection (100 mcg/2mL) | >240 | >240 | Not applicable | Same |
Similar Analysis:
Minor differences on the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance concerns.
Table 5 Biocompatibility comparison
| Item | Proposed device(K233990) | Predicate device(K223903) | Result | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | IrritationISO 10993-23 | Under theconditions of thestudy, not anirritant. | Comply with ISO10993-10 | Same |
| SensitizationISO 10993-10 | Under theconditions of thestudy, not asensitizer. | |||
| Acute SystemicToxicityISO 10993-11 | Under theconditions of thestudy, the deviceextract does notinduce acute | Not available | DifferentAcute systemictoxicity informationfor the predicatedevice is not publicly |
{12}------------------------------------------------
| systemic toxicity | available. This doesnot raise different | ||
|---|---|---|---|
| response. | safety orperformance | ||
| questions since thesubject device hasacceptablebiocompatibility perthe biocompatibilityendpointassessment. |
G. Summary of Non-Clinical Testing
A Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is Surface and External Communicating Device category and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to evaluate the biocompatibility of Nitrile Disposable Examination Gloves as per Guidance for Industry and FDA Staff -Medical Glove Guidance Manual issued on January 22, 2008:
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity
A Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (2022) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions (width)(thickness)ASTM D6319-19 | The purpose of the test is toevaluate the physicaldimension of the glove | Length240mm min | Pass |
| Width | |||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120 ± 10mm |
{13}------------------------------------------------
| XXL: 130±10mm | |||
|---|---|---|---|
| Palm - 0.05mm min. | Pass | ||
| Finger - 0.05mm min. | |||
| Physical propertiesASTM D6319-19 | The purpose of the test is toevaluate the tensile strengthand ultimate elongationbefore and after aging | Tensile Strength:Before Aging ≥14 MPa, min.After Aging ≥14 MPa, min.Elongation:Before Aging 500%, min.After Aging 400%, min. | Pass |
| Freedom from holesASTM D5151-19 | The purpose of the test is todetect holes in the gloves | No leakage at sampling level of G-1,AQL 2.5 | Pass |
| Residual PowderASTM D6124-06(2022) | The purpose of the test is todetect the powder residue inthe glove | <2mg per glove | Pass |
| Permeation byChemotherapyDrugsASTM D6978-05(2019) | The purpose of the test is todetect the Permeation timeby Chemotherapy Drugs ofthe glove | Refer the above table 4 | Pass |
H. Clinical Test Conclusion
No clinical study is included in this submission.
l. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K223903.
§ 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.