(238 days)
The glove 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.
Powder Free Nitrile Examination Glove (Grev) Tested for Use with Chemotherapy Drugs and Fentany) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The document is a US FDA 510(k) premarket notification for "Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K223713). It is not a report on a study proving a device meets acceptance criteria for an AI/ML medical device, but rather a submission for a physical medical device (gloves).
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, including details like "sample size used for the test set," "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance," cannot be extracted from this document, as it discusses the physical properties and chemical permeation resistance of examination gloves.
The tables in the document describe the performance of the gloves against various chemotherapy drugs and Fentanyl Citrate, and their physical properties and biocompatibility.
Here's the closest interpretation of the request using the provided document's context of a physical device:
Acceptance Criteria and Device Performance (for Examination Gloves)
This document describes the testing and acceptance criteria for Powder Free Nitrile Examination Gloves. The "Acceptance Criteria" refer to the performance standards the gloves must meet to be considered safe and effective for their indicated use, especially concerning resistance to chemotherapy drugs and fentanyl citrate. The "Reported Device Performance" shows the results for the applicant's specific glove product.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides these in a combined table under "Summary of Non-Clinical Performance Data" and "Technological Characteristic Comparison Table: Chemotherapy Permeation and Fentanyl Citrate Comparison Claim."
Non-Clinical Performance Data Summary (from page 10):
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to table of specific drug breakthrough times | Pass (See details below for specific drugs) |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential toxicity to L929 cells.* |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
*Note on Cytotoxicity: The document states "showed potential toxicity to L929 cells" for cytotoxicity but then indicates "Cytotoxicity concern was addressed by acute systematic toxicity testing" in the comparison table (page 6), where the Acute Systematic Toxicity test result was "no evidence of systemic toxicity." This implies the potential in vitro toxicity was deemed acceptable given no in vivo systemic toxicity.
Chemotherapy Drug and Fentanyl Citrate Permeation (pages 5 & 6 and 8 & 9):
The acceptance criterion for most drugs is a minimum breakthrough detection time, often stated as ">240 minutes". The reported device performance is presented alongside the predicate and reference devices.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) (Subject Device K223713) |
|---|---|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| ... (many drugs listed as >240 minutes) ... | ... |
| Thiotepa (10 mg/ml) | 44.4 |
| ... (more drugs listed as >240 minutes) ... | ... |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Mix 50/50 | >240 |
Important Note: The document explicitly states: "*Please note that the following drugs have extremely low permeation times: Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes. Warning: Do not use with Carmustine and Thio Tepa." This indicates that for these two specific drugs, the gloves do not meet a desired long-duration protection, and this is communicated as a warning on the label. For all other listed drugs, the glove achieved a breakthrough time of >240 minutes, meeting the implicit acceptance given the context of other drugs and the "Pass" result in the summary table.
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of gloves or individual tests) used for each physical, chemical permeation, or biocompatibility test. It only states "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
- Data Provenance: The tests were conducted to specific ASTM and ISO standards. The manufacturer, Better Care Plastic Technology Co., Ltd, is located in China (Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China). The testing data would originate from their internal testing or third-party labs they commissioned. The document does not specify if the data is retrospective or prospective, but for such device testing, it is typically prospective, meaning the tests were performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the testing of physical gloves. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic AI/ML devices where human interpretation is the gold standard. For these gloves, the "ground truth" is established by direct physical and chemical measurements following globally recognized standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for establishing consensus ground truth in medical image interpretation for AI/ML studies. Here, the results are direct measurements.
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. An MRMC study is for evaluating human performance (e.g., radiologists) with and without AI assistance for diagnostic tasks. This document is about the physical properties of medical gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This concept pertains to AI algorithms performing diagnostic tasks independently. The "device" here is a physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of the gloves is based on:
- Direct Physical Measurements: e.g., length, palm width, thickness, tensile strength, elongation, water leak rate, powder residue, all conducted according to specified ASTM standards.
- Chemical Permeation Testing: Direct measurement of breakthrough time for specific chemotherapy drugs and fentanyl citrate using ASTM D6978-05 (2019) standard.
- Biocompatibility Testing: In vitro cytotoxicity (ISO 10993-5), dermal irritation and skin sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11), where "ground truth" is determined by the specific biological responses observed as per the standard's criteria.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model or "training set" for physical examination gloves.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 7, 2023
Better Care Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K223713
Trade/Device Name: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: July 6, 2023 Received: July 6, 2023
Dear Kathy Liu:
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.
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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.
Bifeng Qian -S
Bifeng Qian, M.D., 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) K223713
Device Name
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The glove 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.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| Cetuximab (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Cytarabine (Cytosine) (100 mg/ml) | >240 |
| Cytovene (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCL (5 mg/ml) | >240 |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 |
| Eribulin Mesylate (0.5 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| 5-Fluorouracil (50 mg/ml) | >240 |
| Fulvestrant (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCL (20 mg/ml) | >240 |
| Mechlorethamine HCL (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin-C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |
{3}------------------------------------------------
| Pertuzumab (30 mg/ml) | >240 |
|---|---|
| Raltitrexed monohydrate (0.5 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Temsirolimus (25 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 44.4 |
| Topotecan HCL (1 mg/ml) | >240 |
| Trastuzumab (21 mg/ml) | >240 |
| Trisenox (1 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincrinstine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (0.8 mg/ml) | >240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time (Minutes) |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510(K) SUMMARY
The assigned 510(K) numbers: K223713 Date Prepared: August 2, 2023
1. Owner's Identification:
Mrs. Zhu Chunyan Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China Tel:86-311-66179668 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel:909-590-1611 Email: fdareg@hongray.com.cn or kathyliu(@hongrayusa.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Non-Powdered Patient Examination Glove Specialty Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Primary Predicate Device: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs and Fentany! Citrate (K221269)
Reference device:
O & M Halyard, Inc.
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230)
This reference device is being used to support inclusion of additional chemotherapy drugs that were not tested in the predicate.
4. Device Description:
Powder Free Nitrile Examination Glove (Grev) Tested for Use with Chemotherapy Drugs and Fentany) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
The glove 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.
{5}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
The following chemicals have been tested with these gloves: Table 1
| Chemotherapy Drugand Concentration | Minimum Breakthrough DetectionTime(Minutes) |
|---|---|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| Cetuximab (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Cytarabine (Cytosine) (100 mg/ml) | >240 |
| Cytovene (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCL (5 mg/ml) | >240 |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 |
| Eribulin Mesylate (0.5 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| 5-Fluorouracil (50 mg/ml) | >240 |
| Fulvestrant (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCL (20 mg/ml) | >240 |
| Mechlorethamine HCL (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin-C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |
| Pertuzumab (30 mg/ml) | >240 |
| Raltitrexed monohydrate (0.5 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Temsirolimus (25 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 44.4 |
| Topotecan HCL (1 mg/ml) | >240 |
| Trastuzumab (21 mg/ml) | >240 |
| Trisenox (1 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincrinstine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (0.8 mg/ml) | >240 |
{6}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time(Minutes) |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | >240 |
*Please note that the following drugs have extremely low permeation times: Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes
Warning: Do not use with Carmustine and Thio Tepa.
6. Comparison of Subject Device and Predicate Device:
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs & Fentanyl Citrate of the proposed and predicate devices. General Comparison Table:
| Subject DeviceK223713 | Predicate DeviceK221269 | Reference DeviceK191230 | Comparison | |
|---|---|---|---|---|
| Trade Name | Powder Free NitrileExamination Glove (Grey)Tested for Use withChemotherapy Drugs andFentanyl Citrate | Powder Free NitrileExamination Glove (Blue)Tested for Use withChemotherapy Drugs andFentanyl Citrate | Halyard Sterling* NitrilePowder-Free ExamGloves, Halyard SterlingSG* Nitrile Sensi-GuardPowder-Free ExamGloves | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC,QDO | LZC | Different * |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indications for Use | The device is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.These gloves were tested foruse with chemotherapy drugsand Fentanyl listed on thelabel. | The device is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.These gloves were tested foruse with chemotherapy drugsand Fentanyl listed on thelabel. | The device is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer.These gloves were testedfor use withchemotherapy drugslisted on the label. | Same asK221269* |
| Material | Nitrile | Nitrile | Nitrile | Same |
| Powder or PowderFree | Powder Free | Powder Free | Powder Free | Same |
| Color | Grey | Blue | Grey | DifferentfromK221269**Same asK191230 |
| Single use | Single use | Single use | Single use | Same |
| Dermal IrritationISO 10993-10 | Based on the criteria, the testarticle extracts wereconsidered negligibleirritants. | Under the conditions of thestudy, not an irritant | Based on the criteria andconditions of the study,the test article wasconsidered nonirritating | Same |
| Dermal SensitizationISO 10993-10 | Based on the criteriaand conditions of thestudy, the test article isclassified as a non-sensitizer | Under the conditions of thestudy, not a sensitizer | Based on the criteria andconditions of the study,the test article showedno evidence of causingdelayed dermal contactsensitization | Same |
| Cytotoxicity TestISO 10993-5 | / | Under the conditions of thisstudy, the test article extractshowed potential toxicity toL929 cells.Cytotoxicityconcernwasaddressed by acute systematictoxicity testing. | / | DifferentfromK221269Same asK191230 |
| Acute SystemicToxicityISO 10993-11 | Based on the criteria, the testarticle meets the requirements | Under the conditions of thisstudy, there was no evidenceof systemic toxicity. | No mortality of evidenceof systemic toxicityfrom the extracts | Same |
| Chemotherapy Drugsand Fentanyl CitrateClaim | See below comparison table | See below comparison table | See below comparisontable | / |
| TechnologicalCharacteristics | Subject DeviceK223713 | Predicate DeviceK221269 | Reference DeviceK191230 | Comparison |
| Physical Dimension | ||||
| Length | Minimum 230mm | Minimum 230mm | Minimum 230mm | Same |
| Palm Width (size) (mm) | ||||
| XS | 70±10 | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | 120±10 | Same |
| Thickness(mm) | ||||
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Physical Property | ||||
| Tensile Strength, BeforeAging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,Before Aging | 500%, min | 500%, min | 500%, min | Same |
| Tensile Strength, AfterAccelerated Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, AfterAccelerated Aging | 400%, min | 400%, min | 400%, min | Same |
| Watertight (1000ml) | G-I, AQL2.5 | G-I, AQL2.5 | G-I, AQL2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | ≤2 mg per glove | Same |
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Better Care Plastic Technology Co., Ltd
Fuqian Xi Road, West district of Shenze, Industrial Base,
{8}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
- QDO and OPJ, both designated for Medical Gloves with Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs, the subject device added the product code OPJ as per reguirements but does not raise questions of safety and effectiveness.
** The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not raise questions of safety and effectiveness.
Technological Characteristic Comparison Table:
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and | Minimum Breakthrough Detection Time (Minutes) | Comparison | ||
|---|---|---|---|---|
| Concentration | Subject Device | Reference Device | Predicate Device | With |
| K223713 | K191230 | K221269 | K191230 | |
| Arsenic Trioxide (1 mg/ml) | >240 | >240 | / | Same |
| Azacitidine (25 mg/ml) | >240 | >240 | / | Same |
| Bendamustine HCL (5 mg/ml) | >240 | >240 | / | Same |
| Bleomycin sulfate (15 mg/ml) | >240 | >240 | >240 | Same |
| Bortezomib (1 mg/ml) | >240 | >240 | / | Same |
| Busulfan (6 mg/ml) | >240 | >240 | >240 | Same |
| Carboplatin (10 mg/ml) | >240 | >240 | >240 | Same |
| Carfilzomib (2 mg/ml) | >240 | >240 | / | Same |
| Carmustine (3.3 mg/ml) | 13.9 | 14.8 | 11.1 | Similar |
| Cetuximab (2 mg/ml) | >240 | >240 | / | Same |
| Cisplatin (1 mg/ml) | >240 | >240 | >240 | Same |
| Cyclophosphamide (20 mg/ml) | >240 | >240 | >240 | Same |
| Cytarabine (Cytosine) (100 mg/ml) | >240 | >240 | >240 | Same |
| Cytovene (10 mg/ml) | >240 | >240 | / | Same |
| Dacarbazine (DTIC) (10 mg/ml) | >240 | >240 | >240 | Same |
| Daunorubicin HCL (5 mg/ml) | >240 | >240 | >240 | Same |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 | >240 | / | Same |
| Docetaxel (10 mg/ml) | >240 | >240 | >240 | Same |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 | >240 | >240 | Same |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 | >240 | >240 | Same |
| Eribulin Mesylate (0.5 mg/ml) | >240 | >240 | / | Same |
| Etoposide (Toposar) (20 mg/ml) | >240 | >240 | >240 | Same |
| Fludarabine (25 mg/ml) | >240 | >240 | >240 | Same |
| 5-Fluorouracil (50 mg/ml) | >240 | >240 | >240 | Same |
| Fulvestrant (50 mg/ml) | >240 | >240 | / | Same |
| Gemcitabine (38 mg/ml) | >240 | >240 | >240 | Same |
| Idarubicin (1.0 mg/ml) | >240 | >240 | >240 | Same |
| Ifosfamide (50 mg/ml) | >240 | >240 | >240 | Same |
| Irinotecan HCL (20 mg/ml) | >240 | >240 | >240 | Same |
| Mechlorethamine HCL (1 mg/ml) | >240 | >240 | >240 | Same |
| Melphalan (5 mg/ml) | >240 | >240 | >240 | Same |
| Methotrexate (25 mg/ml) | >240 | >240 | >240 | Same |
| Mitomycin-C (0.5 mg/ml) | >240 | >240 | >240 | Same |
| Mitoxantrone (2 mg/ml) | >240 | >240 | >240 | Same |
| Oxaliplatin (2 mg/ml) | >240 | >240 | >240 | Same |
| Paclitaxel (6 mg/ml) | >240 | >240 | >240 | Same |
| Paraplatin (10 mg/ml) | >240 | >240 | >240 | Same |
| Pemetrexed (25 mg/ml) | >240 | >240 | / | Same |
| Pertuzumab (30 mg/ml) | >240 | >240 | / | Same |
| Raltitrexed monohydrate (0.5 mg/ml) | >240 | >240 | / | Same |
| Retrovir (10 mg/ml) | >240 | >240 | >240 | Same |
| Rituximab (10 mg/ml) | >240 | >240 | >240 | Same |
| Temsirolimus (25 mg/ml) | >240 | >240 | / | Same |
| Thiotepa (10 mg/ml) | 44.4 | 23.9 | 21.6 | Similar |
| Topotecan HCL (1 mg/ml) | >240 | >240 | >240 | Same |
| Trastuzumab (21 mg/ml) | >240 | >240 | / | Same |
| Trisenox (1 mg/ml) | >240 | >240 | >240 | Same |
| Vinblastine (1 mg/ml) | >240 | >240 | / | Same |
| Vincrinstine Sulfate (1 mg/ml) | >240 | >240 | >240 | Same |
| Vinorelbine (10 mg/ml) | >240 | >240 | / | Same |
| Zoledronic Acid (0.8 mg/ml) | >240 | >240 | / | Same |
| Tested Fentanyl Citrate and Concentration | ||||
| Fentanyl Citrate Injection (100mcg/2mL) | >240 | / | >240 | Different* |
| Simulated Gastric Acid Fluid/Fentanyl CitrateInjection Mix 50/50 Solution | >240 | / | / | Different* |
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Fuqian Xi Road, West district of Shenze, Industrial Base,
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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different does not raise questions of safety and effectiveness.
7. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 220mm for size XSand S, 230mm for size M, L, XL | Pass |
| ASTM D6319- 19 | Physical Dimensions PalmWidth | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL: 120±10mm | Pass |
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min14 Mpa)and Elongation (Before Aging500% and after aging 400%) Min | Pass |
| ASTM D6319- 19ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by ChemotherapyDrugs | Refer the above table 1 | Pass |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skinirritation | Is non-sensitizationand Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potentialtoxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed no adversebiological reaction | no evidence of acutesystemic toxicity. |
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ●
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●
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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ●
- ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-● Tension
- ASTM D6978-05 (Reapproved 2019). Assessment of Reissuance of Medical Gloves to Permeation by . Chemotherapy Drugs.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin ● Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ●
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
- Summary of Clinical Testing: Not provided for the subject device.
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
§ 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.