(96 days)
Not Found
No
The device is a physical examination glove and the summary focuses on its material properties and resistance to chemicals, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination, not to provide therapy or treatment.
No
This device is a glove, used to prevent contamination between a patient and examiner. It does not provide any diagnostic information.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand or finger. It undergoes physical and chemical testing, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of this device is to be worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is a barrier device for protection, not for analyzing biological samples.
- Device Description: The description focuses on the physical properties and chemical resistance of the glove, not on any diagnostic function.
- Performance Studies and Metrics: The performance studies and key metrics are related to the glove's physical integrity, chemical resistance, and biocompatibility, not to diagnostic accuracy (like sensitivity, specificity, etc.).
This device is a medical glove, specifically a patient examination glove and specialty chemotherapy glove. Its purpose is to provide a protective barrier, not to perform a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Test Chemotherapy drug are as followings:
| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 1.3 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 1.1 |
Test Fentanyl Citrate are as follows: Fentanyl Citrate Injection 100mcg/2ml
Warning: Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.3 minutes and Thiotepa:1.1 minutes.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTMD6978- 05(2019). The gloves are single use, disposable, and provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D6319-19: Physical Dimensions (Length, Palm Width, Thickness) - Pass
- ASTM D6319-19, ASTM D412-16 (2021): Physical Properties (Before aging: Tensile strength, Ultimate elongation; After aging: Tensile strength, Ultimate elongation) - Pass
- ASTM D6319-19, ASTM D5151-19: Water leak test (AQL 2.5) - Pass
- ASTM D6319-19, ASTM D6124-06 (2017): Powder Residue (Max 2mg/glove) - Pass
- ASTM D6978-05 (2019): Permeation by Chemotherapy Drugs (Refer table in Indications for Use) - Pass
- ISO 10993-10:2021: Skin Sensitization - The sample extract elicits no sensitization reactions under the test conditions.
- ISO 10993-23:2021: Irritation - Under the conditions of this study, the irritation response category of the test article is classified as Negligible for polar extract and Negligible for non-polar extract.
- ISO 10993-11:2017: Acute systemic toxicity study - No death or acute systemic toxicity was observed in the mice which received injection of extract.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 8, 2024
Yue Kang Anhui Medical Products Co., Ltd Amy Gao Ouality Engineer No 375, Yunjin Road Huaibei. Anhui 235000 China
Re: K240021
Trade/Device Name: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: March 8, 2024 Received: March 8, 2024
Dear Amy Gao:
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 (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240021
Device Name
Powder Free Nittile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
Powder Free Nitrile Examination Glove 3.5, Blue Color. Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentany] 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Test Chemotherapy drug are as followings:
| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 1.3 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 1.1 |
Test Fentanyl Citrate are as follows: Fentanyl Citrate Injection 100mcg/2ml
Warning: Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.3 minutes and Thiotepa:1.1 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.
240
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4
510(K) SUMMARY (K240021)
Date Prepared: April 3, 2024
1. Owner's Identification:
Applicant Name: Yue Kang Anhui Medical Products Co., Ltd Location: No 375, Yunjin Road, Huaibei City, Anhui, China Contact Person: Amy Gao Tel: +86-18266365220
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Common Name: Exam Gloves Classification Name: Non-Powdered Patient Examination Glove Specialty Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Professional Latex Sdn Bhd Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088) Product code LZA, LZC, QDO, OPJ.
4. Device Descrintion:
Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTMD6978- 05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
5
| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 1.3 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 1.1 |
| Test Fentanyl Citrate are as follows: | Minimum Breakthrough Detection Time in minutes |
|---|---|
| --------------------------------------- | ------------------------------------------------ |
Fentanyl Citrate Injection 100mcg/2ml
Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.3 minutes and Thiotepa:1.1 minutes.
240
6. Comnarison of Subiect Device and Predicate Device:
The following tables are summaries of the technological characteristics, biocompatibility and
testing for use with chemotherapy drugs & Fentanyl Citrate of the proposed and predicate devices.
General Comparison Table:
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| 510K # | K240021 | K220088 | N/A |
| Product Name | Powder Free Nitrile Examination | ||
| Glove 3.5, Blue Color, Non-Sterile, | |||
| and Tested for Use with | |||
| Chemotherapy Drugs and Fentanyl | |||
| Citrate | Powder Free Nitrile Examination | ||
| Glove, Non-Sterile, and Tested for | |||
| Use with Chemotherapy Drugs and | |||
| Fentanyl Citrate | Different | ||
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for | |||
| use | Powder Free Nitrile Examination | ||
| Glove 3.5, Blue Color, Non-Sterile, | |||
| and 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. | |||
| These gloves were tested for use | |||
| with Chemotherapy Drugs and | |||
| Fentanyl Citrate as per ASTM | |||
| D6978-05 (Reapproved 2019) | Powder free Nitrile Examination | ||
| Gloves, Non-Sterile and tested for | |||
| use with Chemotherapy Drugs and | |||
| Fentanyl Citrate is a patient medical | |||
| exam gloves which is a disposal device | |||
| intended for medical purposes that is | |||
| worn on the examiners' hand or | |||
| finger to prevent contamination | |||
| between examiner and patient. | |||
| The glove was tested for use with | |||
| Chemotherapy Drugs and Fentanyl | |||
| Citrate as per ASTM D6978-05 | Same |
6
| Standard Practice for Assessment of
Medical Gloves to Permeation by
Chemotherapy Drugs. | Standard Practice for Assessment of
Medical Gloves to permeation by
chemotherapy Drugs | | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------|-----------|
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Different |
| Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Different |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single use | Single use | Same |
| Chemotherapy Drugs and Fentanyl Citrate Claim | See below comparison table | See below comparison table | Same |
Analysis: The proposed device has size XS, S, M, L, XL, XXL, while the predicate device has size XS, S, M, L, XL. But performance testing has been done to the proposed device and the results showed that the device meets the requirements of standard ASTM D6319-19. Therefore, this difference does not raise any new safety or performance questions.
Technological Characteristic and Biocompatibility Comparison Table:
| Item | Standard | Proposed device | Predicate device K220088 | Result |
|---|---|---|---|---|
| Dimension | ASTM D6319-19 | Length: Min 230mm | ||
| Width(mm): | ||||
| XS: 70±10 | ||||
| S: 80±10 | ||||
| M: 95±10 | ||||
| L: 110±10 XL: | ||||
| 120±10 XXL: | ||||
| 130±10 | ||||
| Thickness(mm): | ||||
| Palm: Minimum 0.05 | ||||
| Finger: Minimum 0.05 | Length: Min 240mm | |||
| Width(mm): | ||||
| XS: 70±10 | ||||
| S: 80±10 | ||||
| M: 95±10 | ||||
| L: 110±10 XL | ||||
| 120±10 XXL: | ||||
| Thickness:(mm) | ||||
| Palm: Minimum 0.05 | ||||
| Finger: Minimum 0.05 | Similar | |||
| Physical properties | ||||
| Before aging | ||||
| Tensile strength | ||||
| Ultimate elongation | ||||
| After aging | ||||
| Tensile strength | ||||
| Ultimate elongation | ASTM D6319-19 | |||
| ASTM D412-16 | 14MPa, min | |||
| 500%, min | ||||
| 14MPa, min | ||||
| 400%, min | 14MPa, min | |||
| 500%, min | ||||
| 14MPa, min | ||||
| 400%, min | Same | |||
| Freedom from holes | ASTM D6319-19 | |||
| ASTM D5151-19 | G-I, AQL2.5 | G-I, AQL2.5 | Same |
7
| Residual Powder | ASTM D6319-19
ASTM D6124-06 | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
|------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------|
| Biocompatibility | Irritation
ISO 10993-23 | Under the conditions of this
study, the irritation response
category of the test article is
classified as Negligible for
polar extract and Negligible
for non-polar extract. | Under the conditions of the
study, the subject device is
non- irritating | Similar① |
| | Sensitization
ISO 10993-10 | The sample extract elicits no
sensitization reactions under
the test conditions | Under the condition of the
study, the subject device is
non-sensitizer | Similar |
| | Acute Systemic
Toxicity Test
ISO 10993 -11 | No death or acute systemic
toxicity was observed in the
mice which received
injection of the extract | Under the conditions of the
study, the subject showed no
adverse biological reaction | Similar |
() The new version of standard for Skin Irritation we refer is ISO 10993-23:2021, the test method and process is the same as the old version ISO 10993-10
Chemotherapy drug Permeation and Fentanyl Citrate Comparison Claim:
| Chemotherapy Drug | Minimum Breakthrough Detection
Time (Minutes) | | Remark |
|---------------------------------|--------------------------------------------------|-----------------------------|-----------|
| | Proposed device | Predicate device
K220088 | |
| Carmustine (BCNU) (3.3mg/ml) | 1.3 | 24.3 | Different |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (20mg/ml) | >240. | >240 | Same |
| Dacarbazine (10.0 mg/ml) | >240 | >240 | Same |
| Doxorubicin HCl (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 1.1 | 48.6 | Different |
| Ifosfamide (50.0 mg/ml) | / | >240 | Different |
| Mitoxantrone (2.0 mg/ml) | / | >240 | Different |
| Vincristine Sulfate (1.0 mg/ml) | / | >240 | Different |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different does not raise questions of safety and effectiveness.
| Minimum Breakthrough Detection Time (Minutes) | |||
|---|---|---|---|
| Fentanyl Citrate | Proposed device | Predicate device | |
| K220088 | Remark | ||
| Fentanyl Citrate Injection, 100mcg/2mL | >240 | >240 | Same |
Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications.
The test results demonstrated that the proposed device met the performance criteria with the following standards:
8
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions | ||
| Length | Minimum 220mm for size XS | ||
| and S, 230mm for size M, L, XL | Pass | ||
| ASTM D6319- 19 | Physical Dimensions Palm | ||
| Width | XS: 70±10mm | ||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm XL: | |||
| 120±10mm | |||
| XXL: 130±10mm | Pass | ||
| ASTM D6319- 19 | Physical Dimensions | ||
| Thickness | Finger: 0.05mm (min) | ||
| Palm: 0.05mm (min) | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D412-16 (2021) | Physical Properties | Before aging: 14MPa, min | |
| 500%, min | |||
| After aging: 14MPa, min | |||
| 400%, min | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859- 1) | Pass |
| ASTM D6319- 19 | |||
| ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by | ||
| Chemotherapy Drugs | Refer the above table 1 | Pass | |
| ISO 10993-10:2021 | Skin Sensitization | No Skin sensitization | The sample extract |
| elicits no sensitization | |||
| reactions under the | |||
| test conditions | |||
| ISO 10993-23:2021 | Irritation | No Skin irritation | Under the conditions of |
| this study, the irritation | |||
| response category of the | |||
| test article is classified | |||
| as Negligible for polar | |||
| extract and Negligible | |||
| for non-polar extract. | |||
| ISO 10993-11:2017 | Acute systemic toxicity | ||
| study | Subject showed no adverse | ||
| biological reaction | No death or acute | ||
| systemic toxicity was | |||
| observed in the mice | |||
| which received injection | |||
| of extract |
9
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. .
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves .
ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization.
- ISO10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity .
7. Summary of Clinical Testing:
Not provided for the subject device.
8. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K.220088, Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.