(28 days)
The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.
The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.
There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.
The materials and the manufacturing process technology are the same.
The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set or data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications for an AI/ML device.
- Adjudication method for an AI/ML device test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
- Standalone performance of an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set of an AI/ML device.
- How the ground truth for an AI/ML training set was established.
However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.
Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves
This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing of Gloves):
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Test | Length (mm): XS/S/M/L/XL/XXL: ≥230 | Pass |
| Width (mm): XS: 70±10mm; S: 85±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Pass | ||
| ASTM D5151-19 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTM D5151 | Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: 14MPa, min | Pass |
| Ultimate Elongation: 500% min | Pass | ||
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: 14MPa, min | Pass |
| Ultimate Elongation: 400% min | Pass | ||
| ASTM D6124 | Powder Content | Meet the requirements of Less than 2mg per glove | Pass |
| ASTM D6978-05 (2019) | Detect the Permeation time by Chemotherapy Drugs and Fentanyl of the glove | Meet the requirements of ASTM D6978-05. (Specific breakthrough times listed elsewhere in document) | Pass |
| ISO 10993-10 | Irritation and Sensitization | Non-irritating; Non-sensitizer | Under the conditions of the study, not an irritant and not a sensitizer |
| ISO 10993-5 | Cytotoxicity | Non Cytotoxic | Under conditions of the study, not cytotoxic |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
- Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."
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 device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device testing.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
- For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
- For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML 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, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
August 2, 2024
Kanglongda Vietnam Protection Technology Company Limited % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 China
Re: K241970
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, OPJ, ODO, LZC Dated: July 3, 2024 Received: July 5, 2024
Dear Ray Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}------------------------------------------------
Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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) K241970
Device Name
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentany! Citrate
Indications for Use (Describe) The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________ K241970
- Date of Preparation: 07/31/2024 1.
-
- Submitter
KANGLONGDA Vietnam Protection Technology Company Limited
Lot CN 05, Viglacera - Phong Dien Industrial Park, Phong Hoa Commune, Phong Dien District, Thua Thien Hue Province, Vietnam, 49316
Contact Person: Yuxiang Yao Position: Batching Supervisor Tel: +86-13722853299
Email: yaoyuxiang 1212@126.com
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
-
- Subject Device Identification
Trade Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Subject Device Identification
Common Name: Medical Examination Glove
Regulatory Information:
Classification: I
Product Code: LZA, LZC, OPJ, QDO
Regulation Number: 21 CFR 880.6250
Review Panel: General Hospital
{5}------------------------------------------------
5. Predicate Device Identification
Predicate Device:
510(k) Number: K202356
Product Name: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
Manufacturer: Kanglongda Vietnam Protection Technology Company Limited
Regulatory Information:
Classification: I
Product Code: LZA
Regulation Number: 21 CFR 880.6250
Review Panel: General Hospital
Common Name: Nitrile Patient Examination Gloves (Powder Free)
Reference Device:
510(k) Number: K240629
Product Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Manufacturer: Xingyu Medical Tech Co., Ltd
Regulatory Information:
Classification: I
Product Code: LZA, LZC, OPJ, QDO
Regulation Number: 21 CFR 880.6250
Review Panel: General Hospital
Common Name: Nitrile Patient Examination Gloves (Powder Free)
Device Description 6.
The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.
The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was
{6}------------------------------------------------
modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM Violet Blue, PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.
There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.
The materials and the manufacturing process technology are the same.
We selected K240629 as our reference device and K202356 as our predicate device. Detailed comparison information can be found in the 510k Summary.
- Indications For Use
The Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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.
| Drugs | Concentration | Minimum BreakthroughDetection Time |
|---|---|---|
| The tested chemotherapy drugs are: | ||
| Carmustine | 3.3 mg/ml(3,300 ppm) | 27.7(35.5,27.7,27.7) |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240min |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240min |
| Dacarbazine | 10mg/ml (10,000 ppm) | >240min |
| Doxorubicin HCl | 2 mg/ml(2,000 ppm) | >240min |
| Etoposide | 20 mg/ml (20,000 ppm) | >240min |
| Fluorouracil | 50mg/ml(50,000 ppm) | >240min |
| Gemcitabine HCl | 38 mg/ml (38,000 ppm) | >240min |
| Ifosfamide | 50mg/ml (50,000 ppm) | >240min |
| Methotrexate | 25mg/ml (25,000 ppm) | >240min |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240min |
| Mitoxantrone HCl | 2 mg/ml (2,000 ppm) | >240min |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240min |
| Thiotepa | 10 mg/ml (10,000 ppm) | 59.4(67.5,59.4,65.9) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240min |
The tested drugs are:
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| The tested non-chemotherapy drugs are: | |||
|---|---|---|---|
| Fentanylinjection | Citrate | 100mcg/2ml | >240min |
Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
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510k Summary
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| 5SC | Concession and Concession Comparison5. .1 | |
| ITEM | 8. Technological Characteristic Comparison SummaryTable 1 Comparison of Technology Characteristics | Remark | ||||
|---|---|---|---|---|---|---|
| Product Code | Proposed Device (K241970)Powder Free Nitrile ExaminationGloves (Blue), Tested for Use withChemotherapy Drugs and FentanylCitrate | Predicate Device(K202356)Powder free Nitrile Examination Gloves(Blue, Violet Blue, White, Cobalt Blue) | Reference Device (K240629)Nitrile Disposable Examination Gloves,Tested for Use with Chemotherapy Drugsand Fentanyl | |||
| Regulation No. | LZA, LZC, OPJ, QDO21 CFR 880.6250 | LZA21 CFR 880.6250 | LZA, LZC, OPJ, QDO21 CFR 880.6250 | SAME | ||
| Class | I | I | I | SAME | ||
| Intended Use | The Powder Free Nitrile ExaminationGloves (Blue), Tested for Use withChemotherapy Drugs and FentanylCitrate is a disposable device intendedfor medical purposes that is worn on theexaminer's hand or finger to preventcontamination between patient andexaminer. | The Powder free Nitrile ExaminationGloves (Blue, Violet Blue, White,Cobalt Blue) is a disposable deviceintended for medical purposes that isworn on the examiner's hands to preventcontamination between patient andexaminer. | The Nitrile Disposable ExaminationGloves, Tested for Use withChemotherapy Drugs and Fentanyl, is adisposable device intended for medicalpurposes that is worn on the examiner'shand or finger to prevent contaminationbetween patient and examiner. The testedchemotherapy drugs are: | SAMESimilar 1 | ||
| The tested chemotherapy drugs are: | ||||||
| Drugs | Concentration | Drugs | Concentration | Minimum BreakthroughDetection Time | ||
| The tested chemotherapy drugs are: | ||||||
| Bleomycin sulfate | Bleomycin sulfate | (15.0 mg/ml 15,000 ppm) | >240 min | |||
| Carboplatine | Carboplatine | (10.0 mg/ml 10,000 ppm) | >240 min | |||
| Carmustine | Carmustine (BCNU) | (3.3mg/ml 3,300-ppm) | 26.7 | |||
| Cisplatin | 1mg/ml (1,000ppm) | Cisplatin | (1.0-mg/ml. 1,000 ppm) | >240 min | ||
| Cyclophosphamide | (20.0 mg/ml. 20,000 ppm) | Cyclophosphamide | (20.0 mg/ml. 20,000 ppm) | >240 min | ||
| Cytarabine, (Cytosine) | (100.0 mg/mL 100,000 ppm) | |||||
| Dacarbazine | (10.0-mg/mL 10,000 ppm) | Dacarbazine | 10mg ml (10,000 ppm) | >240 min | ||
| Doxorubicin HCL | (2.0-mg/ml 2,000 ppm) | Doxorubicin HCl | 2mg/ml(2,000 ppm) | >240 min | ||
| Etoposide (Toposar)+ | (20.0 mg/mL 20,000 ppm) | Etoposide | 20mg/ml (20,000 ppm) | >240 min | ||
| Fluorouracil (5-Flu) | (50.0-mg/mL-50,000-ppm) | Fluorouracil | 50mg/ml(50,000ppm) | >240 min | ||
| Idarubicin | (1.0-mg/ml 1,000 ppm) | |||||
| Gemcitabine HCI | Gemcitabine HCI | 38mg/ml (38,000 ppm) | >240 min | |||
| Ifosfamide | (50.0 mg/mL 50,000 ppm) | Ifosfamide | 50mg/ml (50,000 ppm) | >240 min | ||
| Mechlorethamine HCL | (1.0 mg/ml 1,000 ppm) | |||||
| Methotrexate | (25.0 mg/mL 25,000 ppm) | Methotrexate | 25mg/ml (25,000 ppm) | >240 min | ||
| Mitomycin C | Mitomycin C | 0.5 mg/ml(500 ppm) | >240 min | |||
| Mitoxantrone HCL | (2.0 mg/ml. 2,000 ppme | Mitoxantrone HCL | 2 mg/ml (2,000 ppm) | >240 min | ||
| Paclitaxel | (6.0 mg/mL 6,000 ppm) | Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min | ||
| Thiotepa | (10.0 mg/mL 10,000 ppm) | Thiotepa | 10mg/ml (10,000-ppm) | 37.6 | ||
| Vincristine Sulfate | (1.0 mg/mL 1,000 ppm | Vincristine Sulfate | 1 mg ml (1,000ppm) | >240 min | ||
| The tested-non-chemotherapy drugs are: | The tested non-chemotherapy drugs are: | |||||
| MESNA | (100.0 mg/mL 100,000 ppm) | |||||
| Trisenox (Arsenic Trioxide) | (1.0 mg/ml 1,000 ppm) | |||||
| Fentanyl Citrate Injection | (100 mcg/2mL)+ | |||||
| Note: Carmustine and Thiotep haveextremely low permeation times of 26.7and 37.6 minutes respectively. | Note: Carmustine and Thiotepa haveextremely low permeation times of 27.7and 59.4 minutes respectively. |
ഗ
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510k Summary
| Warning: Do Not Use with Carmustine, Thiotepa | Powder free | Material | Color | OTC use | Sterility | Use | Labeling claim | Size and Dimensions (mm) | Thickness (mm) | PhysicalProperties | Freedom from Holes | Powder Content | Warning: Do Not Use with Carmustine, Thiotepa. | Powder free | Material | Color | OTC use | Sterility | Use | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yes | Nitrile | Blue | Yes | Non-sterile | Single use | Tested for Use with Chemotherapy Drugs and Fentanyl | Length:Min 230mm for size XS-XXLWidth:XS:70±10S: 80±10M: 95±10L: 110±10XL: 120±10XXL:130±10 | Finger:0.08-0.14±0.01Palm:0.06-0.10 ±0.01 | Before Aging | After Aging | Be free from holes when tested in accordance with ASTMD5151 | Meet the requirements of ASTM D6124 | Yes | Nitrile | Blue, Violet Blue, White, Cobalt Blue | Yes | Non-sterile | Single use | |||
| Not Tested for use with Chemotherapy Drugs and Fentanyl | Length:Min 230mm for size XS-XLWidth:XS:70±10S: 80±10M: 95±10L: 110±10XL: 120±10 | Finger:0.08-0.14±0.01Palm:0.06-0.10 ±0.01 | Tensile Strength: 14MPa, minUltimate Elongation:500% min | Tensile Strength: 14MPa, minUltimate Elongation:400% min | Be free from holes when tested in accordance with ASTMD5151 | Meet the requirements of ASTM D6124 | |||||||||||||||
| Tested for Use with Chemotherapy Drugs and Fentanyl | Length:Min 220mm for size SMin 230mm for size M-XLWidth:S: 80±10M: 95±10L: 110±10XL: 120±10 | Finger: ≥0.05; Palm: ≥0.05 | |||||||||||||||||||
| Tensile Strength: 14MPa, minUltimate Elongation:500% min | Tensile Strength: 14MPa, minUltimate Elongation:400% min |
く
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| . Summary |
|---|
| 0k |
| 1ﺎ |
| U> |
| Chemotherapy and non-chemo therapy Drugs Tested with Minimum Breakthrough Detection Time as tested per ASTM D6978 | NA | Similar 2 | Biocompatibility | |||
|---|---|---|---|---|---|---|
| Minimum Breakthrough Detection Time | Drugs | Concentration | Minimum Breakthrough Detection Time | |||
| 27.7(35.5,27.7,27.7) | The tested chemotherapy drugs are:Carmustine | 3.3 mg/ml(3,300 ppm) | >240 min | Irritation and Sensitization:Under the conditions of the study, not an irritant and not a sensitizer | ||
| >240min | Cisplatin | 1 mg/ml (1,000ppm) | >240 min | |||
| >240min | Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min | |||
| >240min | Dacarbazine | 10ng/ml (10,000 ppm) | >240 min | |||
| >240min | Doxorubicin HCL | 2 mg/ml(2,000 ppm) | >240 min | |||
| >240rain | Etoposide | 20 mag/ml (20,000 ppm) | >240 min | |||
| >240min | Fluorouracil | 50ng/ml (50,000 ppm) | >240 min | |||
| >240min | Gemcitabine HCL | 38mg/ml (38,000 ppm) | >240 min | |||
| >240min | Ifosfamide | 50ng/ml (50,000 ppm) | >240 min | |||
| >240min | Methotrexate | 25mg/ml (25,000 ppm) | >240 min | |||
| >240rain | Mitomycin-C | 0.5 mg ml(500 ppm) | >240 min | Irritation and Sensitization:Under the conditions of the study, not an irritant and not a sensitizer | ||
| >240min | Mitoxantrone HCl | 2mg/ml (2,000 ppm) | >240 min | |||
| >240rain | Paclitaxel | 6 mag/ml (6,000 ppm) | >240 min | |||
| 59.4(675,59.4.65.9) | Thiotepa | 10 mag/ml (10,000 ppm) | 37.6 | |||
| >240rain | Vincristine Sulfate | 1 mg/ml (1,000ppm) | >240 min | |||
| >240min | The tested non-chemotherapy drugs are: | |||||
| >240min | Fentanyl Citrate injection | 100mcg/2ml | >240 min | |||
| Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively.Warning: Do Not Use with Carmustine, Thiotepa | ||||||
| Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively.Warning: Do Not Use with Carmustine, Thiotepa. | ISO 10993-10, under the conditions of the study, not an irritant or a sensitizer | |||||
| ISO 10993-11, under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | ||||||
| Cytotoxicity:Under conditions of the study, not cytotoxic | Cytotoxicity:Under conditions of the study, not cytotoxic |
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Similar 1-Indications for use
The proposed device and the reference device have same indications, only minor different drugs and the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance.
Different 1-Size and dimension, Thickness
The size and dimension, Thickness of the proposed device is not exactly same as the predicate and reference device. However, the size and dimension, thickness of the proposed device has been covered by ASTM D6319-19. The user can select appropriate model depended on size of user's hand. In addition, its dimension and thickness have been tested and met the requirement of ASTM D6319-19. Therefore, the difference will not affectiveness of the proposed device.
Similar 2-Chemotherapy and non-chemo therapy Drugs
Only minor differences on different drugs and the penetration time of carmustine and thiotepa between the proposed device and the reference device. And met the requirement of ASTM D6978-05. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
- Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10: 2021 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124-06 (Reapproved 2022), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Test | Length (mm):XS/S/M/L/XL/XXL: ≥230Width(mm):XS: 70±10mm; S: 85±10mm;M: 95±10mm; L: 110±10 mm;XL: 120±10 mmXXL: 130±10 mm | Pass |
Table 2 Summary of non clinical performance testing
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| Thickness (mm):Finger: ≥0.05; Palm: ≥0.05 | Pass | |||
|---|---|---|---|---|
| ASTM D5151-19 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTM D5151 | Pass | |
| ASTM D412 | Physical Properties | Before Aging | Tensile Strength:14MPa, min | Pass |
| Ultimate Elongation:500% min | Pass | |||
| After Aging | Tensile Strength:14MPa, min | Pass | ||
| Ultimate Elongation:400% min | Pass | |||
| ASTM D6124 | Powder Content | Meet the requirements of Less than 2mg per glove | Pass | |
| ASTMD 6978-05 (2019) | Detect the Permeation time by Chemotherapy Drugs and Fentanyl of the glove | Meet the requirements of ASTMD 6978-05. | Pass | |
| ISO 10993-10 | Irritation and Sensitization | Non-irritating; Non- sensitizer | Under the conditions of the study, not an irritant and not a sensitizer | |
| ISO 10993-5 | Cytotoxicity | Non Cytotoxic | Under conditions of the study, not cytotoxic |
10. Summary of Clinical Testing Not applicable
11. Conclusions
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 device, K202356.
§ 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.