(217 days)
The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Bleomycin Sulfate 15 mg/ml >240 min., Carboplatin 10 mg/ml >240 min., Carmustine (BCNU) 3.3 mg/ml 17.2 min., Cisplatin 1.0 mg/ml >240 min., Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min., Cytarabine HCI 100 mg/ml >240 min., Dacarbazine (DTIC)10.0 mg/ml >240 min., Daunorubicin 5.0 mg/ml >240 min., Docetaxel 10.0 mg/ml >240 min, Doxorubicin HCI 2.0 mg/ml >240 min., Etoposide (Toposar) 20.0 mg/ml >240 min., Fluorouracil 50.0 mg/ml >240 min., Gemcitabine 38 mg/ml>240 min., Idarubicin 1 mg/ml >240 min., Ifosfamide 50.0 mg/ml >240 min., Irinotecan 20.0 mg/ml >240 min., Mechlorethamine HCI 1.0 mg/ml>240 min., Melphalan 5 mg/ml >240 min., Methotrexate 25 mg/ml >240 min., Mitromycin C. 0.5 mg/ml >240, Mitoxantrone 2.0 mg/ml >240 min., Paclitaxel (Taxol) 6.0 mg/ml >240 min., Thiotepa 10.0 mg/ml 13.9 min., Vincristine Sulfate 1.0 mg/ml >240 min. Warning: Do not use with Carmustine and Thiotepa.
The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 min., Cisplatin 1.0 mg/ml >240 min., Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min., Dacarbazine (DTIC)10.0 mg/ml >240 min., Doxorubicin HCI 2.0 mg/ml >240 min., Etoposide (Toposar) 20.0 mg/ml >240 min., Fluorouracil 50.0 mg/ml >240 min., Methotrexate 25 mg/ml >240 min., Paclitaxel (Taxol) 6.0 mg/ml >240 min., Thiotepa 10.0 mg/ml 58.3 min. Warning: Do not use with Carmustine and Thiotepa.
The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Black Colored were tested for use with Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Fentanyl Citrate 100mcg/2ml >240 minutes.
Power-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, x-small (6.5"), small (7"), medium (8"), large (8.5"), X-large (9"), XXL (9.5"). Three colors are available for all size, includes blue, blue violet and black. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
The provided document describes the acceptance criteria and study results for "Nitrile Patient Examination Gloves" (various colors) tested for use with chemotherapy drugs or Fentanyl Citrate. This is a medical device, and the evaluation is based on non-clinical performance standards rather than an AI/ML algorithm.
Therefore, many of the requested fields related to AI/ML studies (sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, ground truth for training set, training set size) are not applicable to this submission.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Methodology / Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Dimensions | |||
| Palm width | ASTM D3767-03(2020) | XS (70±10mm)S (80±10mm)M (95±10mm)L (110±10mm)XL (120±10mm)XXL (≥ 120mm) | Pass |
| Length | ASTM D3767-03(2020) | XS (220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min)XXL (230mm min) | Pass |
| Thickness | ASTM D3767-03(2020) | Finger: 0.11mmPalm: 0.05mm | Pass |
| Integrity | |||
| Freedom from holes | ASTM D5151-19 | Freedom free holeAQL 2.5 | Pass |
| Physical Properties (before aging) | |||
| Tensile Strength | ASTM D412-16 | ≥ 14Mpa | Pass |
| Ultimate Elongation | ASTM D412-16 | ≥ 500% | Pass |
| Physical Properties (after aging) | |||
| Tensile Strength | ASTM D573-04(2019) | ≥ 14Mpa | Pass |
| Ultimate Elongation | ASTM D573-04(2019) | ≥ 400% | Pass |
| Chemical Content | |||
| Residual Powder Content | ASTM D6124-06(2017) | ≤2mg per glove | Pass |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic. |
| Acute Systemic Toxicity | ISO 10993-11 | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| Irritation | ISO 10993-10 | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Reapproved 2019) | Min. permeation breakthrough time as specified for each drug | Achieved or exceeded specified times for individual drugs (see detailed lists in pages 2, 4, 5, 7, 8, 11, 12). |
| Fentanyl Citrate Permeation | ASTM D6978-05 (Reapproved 2019) | Min. permeation breakthrough time as specified (e.g., >240 min) | Achieved >240 minutes for Fentanyl Citrate (see detailed lists in pages 5, 8, 12). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard ASTM and ISO methods generally specify sample sizes. For example, AQL 2.5 for "freedom from holes" implies a sampling plan. Since these are performance tests on manufactured goods, the "test set" would be a batch or set of gloves sampled from production.
- Data Provenance: The document does not specify a country of origin for the testing data. The studies are described as "Non clinical tests" performed according to established international standards (ASTM, ISO). They are prospective in the sense that they are performed on the device to be marketed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for these tests is defined by objective physical and chemical measurements according to standardized protocols (ASTM, ISO), not expert interpretation.
4. Adjudication method for the test set
- Not applicable, as the evaluation is based on objective measurements against defined standards.
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 a submission for physical medical gloves, not an AI/ML-driven device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.
7. The type of ground truth used
- The "ground truth" for these tests is the direct measurement of physical properties (e.g., dimensions, tensile strength, elongation), chemical properties (e.g., residual powder content), and barrier properties (permeation breakthrough time for chemotherapy drugs and Fentanyl Citrate) against established, objective industry standards (ASTM, ISO). For biocompatibility, it's the observed biological response to the glove material under controlled test conditions.
8. The sample size for the training set
- Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.
9. How the ground truth for the training set was established
- Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.
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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 27, 2022
Guang Dong Kingfa Sci. & Tech.Co., Ltd. Xiaoge Yu Manager No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K213040
Trade/Device Name: Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Colored Tested For Use With Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: April 16, 2022 Received: April 18, 2022
Dear Xiaoge Yu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213040
Device Name
Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs
Indications for Use (Describe)
The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows:
- · Bleomycin Sulfate 15 mg/ml >240 min.
- · Carboplatin 10 mg/ml >240 min.
- · Carmustine (BCNU) 3.3 mg/ml 17.2 min.
- Cisplatin 1.0 mg/ml >240 min.
- · Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min.
- · Cytarabine HCI 100 mg/ml >240 min.
- · Dacarbazine (DTIC)10.0 mg/ml >240 min.
- Daunorubicin 5.0 mg/ml >240 min.
- · Docetaxel 10.0 mg/ml >240 min
- · Doxorubicin HCI 2.0 mg/ml >240 min.
- · Etoposide (Toposar) 20.0 mg/ml >240 min.
- Fluorouracil 50.0 mg/ml >240 min.
- Gemcitabine 38 mg/ml>240 min.
- · Idarubicin 1 mg/ml >240 min.
- Ifosfamide 50.0 mg/ml >240 min.
- Irinotecan 20.0 mg/ml >240 min.
- · Mechlorethamine HCI 1.0 mg/ml>240 min.
- · Melphalan 5 mg/ml >240 min.
- Methotrexate 25 mg/ml >240 min.
- · Mitromycin C. 0.5 mg/ml >240
- Mitoxantrone 2.0 mg/ml >240 min.
- · Paclitaxel (Taxol) 6.0 mg/ml >240 min.
- · Thiotepa 10.0 mg/ml 13.9 min.
- Vincristine Sulfate 1.0 mg/ml >240 min.
Warning: Do not use with Carmustine and 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.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213040
Device Name
Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotheraoy Drues
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The tested chemotherapy drug are as follows:
- · Carmustine (BCNU) 3.3 mg/ml 65.3 min.
- · Cisplatin 1.0 mg/ml >240 min.
- · Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min.
- · Dacarbazine (DTIC)10.0 mg/ml >240 min.
- · Doxorubicin HCI 2.0 mg/ml >240 min.
- · Etoposide (Toposar) 20.0 mg/ml >240 min.
- Fluorouracil 50.0 mg/ml >240 min.
- · Methotrexate 25 mg/ml >240 min.
- · Paclitaxel (Taxol) 6.0 mg/ml >240 min.
- · Thiotepa 10.0 mg/ml 58.3 min.、
Warning: Do not use with Carmustine and 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213040
Device Name
Nitrile Patient Examination Gloves Black Colored Tested For Use With Fentanyl Citrate
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The Nitrile Patient Examination Gloves Black Colored were tested for use with Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. • Fentanyl Citrate 100mcg/2ml >240 minutes
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{6}------------------------------------------------
510(k) summary: K213040
l. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28 Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn
Preparation date: Apr. 27, 2022
US Agent
Jeff Zhang Ucl-Reg Service Inc 602 Rockwood Rd Wilmington, DE US 19802 Phone: 516 2311209 Email: us-agent@glomed-info.com
II. Proposed Device
| Device Trade Name | Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotherapy Drugs Nitrile Patient Examination Gloves Black Colored Tested For Use With Fentanyl Citrate |
|---|---|
| Common name: | Patient Examination Glove (Tested For Use With Chemotherapy Drugs) |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA, LZC,OPJ, QDO |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K211220 |
|---|---|
| Trade name: | Nitrile Patient Examination Gloves Blue Tested For Use WithChemotherapy Drugs |
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| Nitrile Patient Examination Gloves Blue Violet Tested For UseWith Chemotherapy Drugs | |
|---|---|
| Common name: | Patient Examination Glove |
| Classification: | Class I |
| Product Code: | LZA, LZC,OPJ |
IV. Device description
Power-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, x-small (6.5"), small (7"), medium (8"), large (8.5"), X-large (9"), XXL (9.5"). Three colors are available for all size, includes blue, blue violet and black.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
V. Indication for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Nitrile Patient Examination Gloves Blue Colored Tested Chemotherapy Drugs are as follows:
- Bleomycin Sulfate 15 mg/ml >240 min. .
- Carboplatin 10 mg/ml >240 min. ●
- Carmustine (BCNU) 3.3 mg/ml 17.2 min.
- Cisplatin 1.0 mg/ml >240 min.
- Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. ●
- Cytarabine HCI 100 mg/ml >240 min.
- . Dacarbazine (DTIC)10.0 mg/ml >240 min.
- Daunorubicin 5.0 mg/ml >240 min.
- Docetaxel 10.0 mg/ml >240 min .
- Doxorubicin HCI 2.0 mg/ml >240 min. ●
- Etoposide (Toposar) 20.0 mg/ml >240 min. ●
{8}------------------------------------------------
- Fluorouracil 50.0 mg/ml >240 min. .
- Gemcitabine 38 mg/ml>240 min. ●
- ldarubicin 1 mg/ml >240 min. ●
- lfosfamide 50.0 mg/ml >240 min. ●
- Irinotecan 20.0 mg/ml >240 min. ●
- Mechlorethamine HCI 1.0 mg/ml>240 min. ●
- Melphalan 5 mg/ml >240 min.
- Methotrexate 25 mg/ml >240 min. .
- Mitromycin C. 0.5 mg/ml >240 .
- Mitoxantrone 2.0 mg/ml >240 min. .
- Paclitaxel (Taxol) 6.0 mg/ml >240 min. ●
- Thiotepa 10.0 mg/ml 13.9 min.
- Vincristine Sulfate 1.0 mg/ml >240 min .
Warning: Do not use with Carmustine and Thiotepa.
The Nitrile Patient Examination Gloves Blue Violet Colored Tested Chemotherapy Drugs as follows:
- Carmustine (BCNU) 3.3 mg/ml 65.3 min. ●
- Cisplatin 1.0 mg/ml >240 min. ●
- Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. ●
- Dacarbazine (DTIC)10.0 mg/ml >240 min. ●
- . Doxorubicin HCI 2.0 mg/ml >240 min.
- Etoposide (Toposar) 20.0 mg/ml >240 min.
- . Fluorouracil 50.0 mg/ml >240 min.
- . Methotrexate 25 mg/ml >240 min.
- . Paclitaxel (Taxol) 6.0 mg/ml >240 min.
- . Thiotepa 10.0 mg/ml 58.3 min.
Warning: Do not use with Carmustine and Thiotepa.
The Nitrile Patient Examination Gloves Black Colored Tested with Fentanyl Citrate
- Fentanyl Citrate 100mcg/2ml >240 minutes .
VI. Comparison of technological characteristics with the predicate devices
Proposed device Predicate device ltem Discussion (K213040) (K211220)
Table 1 Comparison of Natural Rubber Surgical Gloves
{9}------------------------------------------------
| Product name | Nitrile PatientExamination GlovesBlue Colored Tested ForUse With ChemotherapyDrugs.Nitrile PatientExamination GlovesBlue Violet ColoredTested For Use WithChemotherapy Drugs.Nitrile PatientExamination GlovesBlack Colored TestedFor Use With FentanylCitrate | Nitrile PatientExamination Gloves BlueTested For Use WithChemotherapy DrugsNitrile PatientExamination Gloves BlueViolet Tested For UseWith ChemotherapyDrugs | - | Color | Blue, Blue violet, Black | Blue, Blue violet | Similar2 |
|---|---|---|---|---|---|---|---|
| Product Code | LZA, LZC,OPJ, QDO | LZA, LZC,OPJ | Similar | Size | x-small, small, medium,large, x-large, XX-large | small, medium, large,x-large | Similar |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | Dimensions –Length | Complies with ASTMD6319-19XS (220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min)XXL (230mm min) | Complies with ASTMD6319-19S (220mm min)M (230mm min)L (230mm min)XL (230mm min) | Same |
| Classification | Class I | Class I | Same | Dimensions –Width | Complies with ASTMD6319-19)XS (70 $\pm$ 10mm)S (80 $\pm$ 10mm)M (95 $\pm$ 10mm)L (110 $\pm$ 10mm)XL (120 $\pm$ 10mm)XXL ( $\ge$ 120mm) | Complies with ASTMD6319-19S (80 $\pm$ 10mm)M (95 $\pm$ 10mm)L (110 $\pm$ 10mm)XL (120 $\pm$ 10mm) | Similar |
| Powder free | Yes | Yes | Same | Dimensions –Thickness | Complies with:ASTM D6319-19Palm: 0.05mm minFinger: 0.11mm min | Complies with:ASTM D6319-19Palm: 0.05mm minFinger: 0.11mm min | Same |
| Indication for use | The nitrile examinationglove is intended to beworn on the hands ofexaminer's to preventcontamination betweenpatient and examiner.This is a single-use,powder-free, non-steriledevice.These gloves weretested for use withchemotherapy drugs perASTM D6978-05(Reapproved 2019)Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs. | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves were testedfor use withchemotherapy drugs asper ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs | Similar | PhysicalProperties | Complies with:ASTM D6319-19minimum:Tensile Strength:Before Aging $\ge$ 14 MPa, min.After Aging $\ge$ 14 MPa, min.Elongation:Before Aging 500%, min.After Aging 400%, min. | Complies with:ASTM D6319-19minimum:Tensile Strength:Before Aging $\ge$ 14 MPa, min.After Aging $\ge$ 14 MPa, min.Elongation:Before Aging 500%, min.After Aging 400%, min. | Same |
| Main Material | Powder-Free Nitrile | Powder-Free Nitrile | Same | Freedom fromHoles | Complies with ASTMD6319-19 and ASTMD5151-19 G-1, AQL 1.5 | Complies with ASTMD6319-19 and ASTMD5151-19 G-1, AQL 1.5 | Same |
| ResidualPowder | Complies with:ASTM D6319-19 | Complies with:ASTM D6319-19 | Same |
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| <2mg per gloveLimited <24 hours | <2mg per gloveLimited <24 hours | ||
|---|---|---|---|
| ContactDurations | Same | ||
| Biocompatibility | ISO 10993-10:Not a skin irritantNot a skin sensitizerAt the neat extraction, thetest article isconsidered cytotoxic, butthe acute systemictoxicity resultsdemonstrate the devicewill not cause a systemiceffect. | ISO 10993-10:Not a skin irritantNot a skin sensitizerAt the neat extraction, thetest article is consideredcytotoxic, but the acutesystemic toxicity resultsdemonstrate the devicewill not cause a systemiceffect. | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Rx Only or OTC | Over the Counter | Over the Counter | Same |
| ChemotherapyDrugs | Nitrile PatientExamination GlovesBlue Colored Tested ForUse With ChemotherapyDrugs | Nitrile PatientExamination Gloves BlueTested For Use WithChemotherapy Drugs | / |
| Bleomycin Sulfate 15mg/ml >240 min. | NA | Similar¹ | |
| Carboplatin 10mg/ml >240 min. | NA | ||
| Carmustine (BCNU) 3.3mg/ml 17.2 min. | Carmustine (BCNU) 3.3mg/ml 65.3 min. | ||
| Cisplatin 1.0 mg/ml >240min. | Cisplatin 1.0 mg/ml >240min. | ||
| Cyclophosphamide(Cytoxan) 20.0mg/ml >240 min. | Cyclophosphamide(Cytoxan) 20.0mg/ml >240 min. | ||
| Cytarabine HCI 100mg/ml >240 min. | NA | ||
| Dacarbazine (DTIC)10.0mg/ml >240 min. | Dacarbazine (DTIC)10.0mg/ml >240 min. | ||
| Daunorubicin 5.0mg/ml >240 min. | NA | ||
| Docetaxel 10.0 mg/ml | NA | ||
| >240 min | |||
| Doxorubicin HCI 2.0mg/ml >240 min. | DoxorubicinHydrochloride 2.0mg/ml >240 min. | ||
| Etoposide (Toposar) 20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0mg/ml >240 min. | ||
| Fluorouracil 50.0mg/ml >240 min. | Fluorouracil 50.0mg/ml >240 min. | ||
| Gemcitabine 38mg/ml>240 min. | NA | ||
| Idarubicin 1 mg/ml >240 min. | NA | ||
| Ifosfamide 50.0mg/ml >240 min. | NA | ||
| Irinotecan 20.0 mg/ml>240 min. | NA | ||
| Mechlorethamine HCI1.0 mg/ml>240 min. | NA | ||
| Melphalan 5 mg/ml >240 min. | NA | ||
| Methotrexate 25mg/ml >240 min. | NA | ||
| Mitromycin C. 0.5mg/ml >240 | NA | ||
| Mitoxantrone 2.0 mg/ml>240 min. | NA | ||
| Paclitaxel (Taxol) 6.0mg/ml >240 min. | Paclitaxel (Taxol) 6.0mg/ml >240 min. | ||
| Thiotepa 10.0 mg/ml13.9 min. | Thiotepa 10.0 mg/ml58.3min. | ||
| Vincristine Sulfate 1.0mg/ml >240 min. | NA | ||
| Nitrile PatientExamination Gloves BlueViolet Colored Tested For UseChemotherapy Drugs | Nitrile PatientExamination Gloves BlueViolet Tested For Use WithChemotherapy Drugs | / | |
| Carmustine (BCNU) 3.3mg/ml 65.3 min. | Carmustine (BCNU) 3.3mg/ml 65.3 min. | Similar¹ | |
| Cisplatin 1.0 mg/ml >240 min. | Cisplatin 1.0 mg/ml >240 min. | ||
| Cyclophosphamide(Cytoxan) 20.0 mg/ml >240 min. | Cyclophosphamide(Cytoxan) 20.0 mg/ml >240 min. | ||
| Dacarbazine (DTIC)10.0 mg/ml >240 min. | Dacarbazine (DTIC)10.0 mg/ml >240 min. | ||
| DoxorubicinHydrochloride 2.0 mg/ml >240 min. | DoxorubicinHydrochloride 2.0 mg/ml >240 min. | ||
| Etoposide (Toposar)20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0 mg/ml >240 min. | ||
| Fluorouracil 50.0 mg/ml >240 min. | Fluorouracil 50.0 mg/ml >240 min. | ||
| Methotrexate 25 mg/ml >240 min. | NA | ||
| DoxorubicinHydrochloride 2.0 mg/ml >240 min. | DoxorubicinHydrochloride 2.0 mg/ml >240 min. | ||
| Etoposide (Toposar)20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0 mg/ml >240 min. | ||
| Nitrile Patient /Examination GlovesBlack Colored Testedwith Fentanyl Citrate | New addblack colorglove2 | ||
| • Fentanyl Citrate100mcg/2ml >240minutes | NA |
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1 Add new 15 kinds of the chemotherapy label claim to the blue colored glove and add one chemotherapy drug test to the blue violet colored glove, which the both of glove has got the clearance under K211220. The permeation testing was conducted per ASTM D6978-05 (Reapproved 2019) to support the addition of the labeling claim.
2 Add a new model glove with black and label claim the device tested by Fentanyl Citrate. Only change the colorant additives during manufacturing. The biocompatibility testing has been conduct on the black gloves and the test results prove the black glove is biologically safe as the previous device. In addition, the physical performances of the proposed device were performed on the final device per ASTM D6319-19.
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VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
| Items | Methodology /Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Palm width | ASTM D3767-03(2020) | XS (70±10mm)S (80±10mm)M (95±10mm)L (110±10mm)XL (120±10mm)XXL ( $\ge$ 120mm) | Pass |
| Length | ASTM D3767-03(2020) | XS (220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min)XXL (230mm min) | Pass |
| Thickness | ASTM D3767-03(2020) | Finger: 0.11mmPalm: 0.05mm | Pass |
| Freedomfrom holes | ASTM D5151-19 | Freedom free holeAQL 2.5 | Pass |
| Physical Properties (before aging) | |||
| TensileStrength | ASTM D412-16 | $\ge$ 14Mpa | Pass |
| UltimateElongation | ASTM D412-16 | $\ge$ 500% | Pass |
| Physical Properties (after aging) | |||
| TensileStrength | ASTM D573-04(2019) | $\ge$ 14Mpa | |
| UltimateElongation | ASTM D573-04(2019) | $\ge$ 400% | Pass |
| ResidualPowderContent | ASTM D6124-06(2017) | ≤2mg per glove | Pass |
| Cytotoxic | ISO 10993-5 | Non-cytotoxic | Underconditions of thestudy, device |
| extract is cytotoxic. | |||
| Acute SystemicToxicity | ISO 10993-11 | Non-acute systemictoxicity | Under conditions ofthe study, did not show acutesystemic toxicityin vivo / Pass |
| Irritation | ISO 10993-10 | Non-irritating | Under theconditions of thestudy, not anirritant/ Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Underconditions of thestudy, not asensitizer./ Pass |
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VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Power-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K211220.
§ 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.