(217 days)
Not Found
No
The 510(k) summary describes a physical medical device (examination gloves) and its performance testing against chemical permeation and physical properties. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device, a nitrile examination glove, is intended for contamination prevention, not for treating or curing a disease or condition.
No
Explanation: The device is a glove intended to prevent contamination, not to diagnose any condition or disease.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "to be worn on the hands of examiner's to prevent contamination between patient and examiner." This is a barrier function for protection, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description reinforces the purpose as a protective barrier for medical purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Testing: The testing described focuses on physical properties, freedom from holes, and resistance to chemotherapy drugs and fentanyl. These are performance characteristics of a protective barrier, not diagnostic performance metrics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
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
Product codes
LZA, LZC, OPJ, QDO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
Items: Palm width
Methodology / Standard: ASTM D3767-03(2020)
Acceptance Criteria: XS (70plusmn10mm), S (80plusmn10mm), M (95plusmn10mm), L (110plusmn10mm), XL (120plusmn10mm), XXL (ge 120mm)
Results: Pass
Items: Length
Methodology / Standard: ASTM D3767-03(2020)
Acceptance Criteria: XS (220mm min), S (220mm min), M (230mm min), L (230mm min), XL (230mm min), XXL (230mm min)
Results: Pass
Items: Thickness
Methodology / Standard: ASTM D3767-03(2020)
Acceptance Criteria: Finger: 0.11mm, Palm: 0.05mm
Results: Pass
Items: Freedom from holes
Methodology / Standard: ASTM D5151-19
Acceptance Criteria: Freedom free hole AQL 2.5
Results: Pass
Items: Physical Properties (before aging) - Tensile Strength
Methodology / Standard: ASTM D412-16
Acceptance Criteria: ge 14Mpa
Results: Pass
Items: Physical Properties (before aging) - Ultimate Elongation
Methodology / Standard: ASTM D412-16
Acceptance Criteria: ge 500%
Results: Pass
Items: Physical Properties (after aging) - Tensile Strength
Methodology / Standard: ASTM D573-04(2019)
Acceptance Criteria: ge 14Mpa
Results: Pass
Items: Physical Properties (after aging) - Ultimate Elongation
Methodology / Standard: ASTM D573-04(2019)
Acceptance Criteria: ge 400%
Results: Pass
Items: Residual Powder Content
Methodology / Standard: ASTM D6124-06(2017)
Acceptance Criteria: le2mg per glove
Results: Pass
Items: Cytotoxic
Methodology / Standard: ISO 10993-5
Acceptance Criteria: Non-cytotoxic
Results: Under conditions of the study, device extract is cytotoxic.
Items: Acute Systemic Toxicity
Methodology / Standard: ISO 10993-11
Acceptance Criteria: Non-acute systemic toxicity
Results: Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
Items: Irritation
Methodology / Standard: ISO 10993-10
Acceptance Criteria: Non-irritating
Results: Under the conditions of the study, not an irritant/ Pass
Items: Sensitization
Methodology / Standard: ISO 10993-10
Acceptance Criteria: Non-sensitizing
Results: Under conditions of the study, not a sensitizer./ Pass
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the 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
2
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 With |
| Chemotherapy Drugs |
7
| | Nitrile Patient Examination Gloves Blue Violet Tested For Use
With 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 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 | Nitrile Patient
Examination Gloves Blue
Tested For Use With
Chemotherapy Drugs
Nitrile Patient
Examination Gloves Blue
Violet Tested For Use
With Chemotherapy
Drugs | - | 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 ASTM
D6319-19
XS (220mm min)
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min)
XXL (230mm min) | Complies with ASTM
D6319-19
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min) | Same |
| Classification | Class I | Class I | Same | Dimensions –
Width | Complies with ASTM
D6319-19)
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 ASTM
D6319-19
S (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 D6319-19
Palm: 0.05mm min
Finger: 0.11mm min | Complies with:
ASTM D6319-19
Palm: 0.05mm min
Finger: 0.11mm min | Same |
| Indication for use | The 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.
These gloves 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. | 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 as
per ASTM D6978-05
(Reapproved 2019)
Standard Practice for
Assessment of Medical
Gloves to Permeation by
Chemotherapy Drugs | Similar | Physical
Properties | Complies with:
ASTM D6319-19
minimum:
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 D6319-19
minimum:
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 from
Holes | Complies with ASTM
D6319-19 and ASTM
D5151-19 G-1, AQL 1.5 | Complies with ASTM
D6319-19 and ASTM
D5151-19 G-1, AQL 1.5 | Same |
| Residual
Powder | Complies with:
ASTM D6319-19 | Complies with:
ASTM D6319-19 | Same | | | | |
10
11
| | 240 min. | NA | Similar¹ |
| | Carboplatin 10
mg/ml >240 min. | NA | |
| | Carmustine (BCNU) 3.3
mg/ml 17.2 min. | Carmustine (BCNU) 3.3
mg/ml 65.3 min. | |
| | 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. | |
| | Cytarabine HCI 100
mg/ml >240 min. | NA | |
| | Dacarbazine (DTIC)10.0
mg/ml >240 min. | Dacarbazine (DTIC)10.0
mg/ml >240 min. | |
| | Daunorubicin 5.0
mg/ml >240 min. | NA | |
| | Docetaxel 10.0 mg/ml | NA | |
| >240 min | | | |
| Doxorubicin HCI 2.0
mg/ml >240 min. | Doxorubicin
Hydrochloride 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. | | |
| Gemcitabine 38
mg/ml>240 min. | NA | | |
| Idarubicin 1 mg/ml >240 min. | NA | | |
| Ifosfamide 50.0
mg/ml >240 min. | NA | | |
| Irinotecan 20.0 mg/ml
240 min. | NA | | |
| Mechlorethamine HCI
1.0 mg/ml>240 min. | NA | | |
| Melphalan 5 mg/ml >240 min. | NA | | |
| Methotrexate 25
mg/ml >240 min. | NA | | |
| Mitromycin C. 0.5
mg/ml >240 | NA | | |
| Mitoxantrone 2.0 mg/ml
240 min. | NA | | |
| Paclitaxel (Taxol) 6.0
mg/ml >240 min. | Paclitaxel (Taxol) 6.0
mg/ml >240 min. | | |
| Thiotepa 10.0 mg/ml
13.9 min. | Thiotepa 10.0 mg/ml
58.3min. | | |
| Vincristine Sulfate 1.0
mg/ml >240 min. | NA | | |
| Nitrile Patient
Examination Gloves Blue
Violet Colored Tested For Use
Chemotherapy Drugs | Nitrile Patient
Examination Gloves Blue
Violet Tested For Use With
Chemotherapy Drugs | / | |
| Carmustine (BCNU) 3.3
mg/ml 65.3 min. | Carmustine (BCNU) 3.3
mg/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. | | |
| Doxorubicin
Hydrochloride 2.0 mg/ml >240 min. | Doxorubicin
Hydrochloride 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 | | |
| Doxorubicin
Hydrochloride 2.0 mg/ml >240 min. | Doxorubicin
Hydrochloride 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 Gloves
Black Colored Tested
with Fentanyl Citrate | | New add
black color
glove2 | |
| • Fentanyl Citrate
100mcg/2ml >240
minutes | NA | | |
12
13
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.
14
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: 0.11mm
Palm: 0.05mm | Pass |
| Freedom
from holes | ASTM D5151-19 | Freedom free hole
AQL 2.5 | Pass |
| Physical Properties (before aging) | | | |
| Tensile
Strength | ASTM D412-16 | $\ge$ 14Mpa | Pass |
| Ultimate
Elongation | ASTM D412-16 | $\ge$ 500% | Pass |
| Physical Properties (after aging) | | | |
| Tensile
Strength | ASTM D573-04(2019) | $\ge$ 14Mpa | |
| Ultimate
Elongation | ASTM D573-04(2019) | $\ge$ 400% | Pass |
| Residual
Powder
Content | ASTM D6124-06(2017) | ≤2mg per glove | Pass |
| Cytotoxic | 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 |
15
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.