(84 days)
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs and Fentanyl Test claim.
The subject device in this 510(k) Notification is EMG Blue Powder Free Nitrile Examination Gloves with Chemotherapy Drugs and Fentanyl Test Claim. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl test claims.
The Blue Nitrile Medical Examination Gloves, Powder Free, is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner (product Code LZA) and are used with chemotherapy drugs (Product code LZC and OPJ) and fentanyl test (Product code QDO).
The provided document is an FDA 510(k) clearance letter for a medical device: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim. This document describes the device's technical specifications and safety testing, not AI/ML algorithm development or performance in a clinical setting.
Therefore, the requested information often found in AI/ML performance studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) is not applicable to this device and is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device and confirming adherence to established physical, chemical, and biological safety standards for examination gloves.
Here's the information that is applicable and can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on various ASTM and ISO standards, primarily related to the physical properties, biocompatibility, and chemical resistance of examination gloves. The "Reported Device Performance" column reflects whether the device met these established standards.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | (Not a quantitative criterion; refers to regulatory classification) | LZA, LZC, OPJ, and QDO |
| Intended Use | Prevent contamination between patient and examiner; tested for chemotherapy drugs and fentanyl. | Meets intended use. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | Blue | Blue |
| Sterility | Non-sterile | Non-sterile |
| Surface | Finger Textured | Finger Textured |
| Cuffing Beading | Rolled Beading | Rolled Beading |
| Design | Ambidextrous | Ambidextrous |
| Overall Length (mm) | Min 230mm (ASTM D6319-19) | Meets ASTM D6319-19 (Min 230mm) |
| Width (± 10mm) | Size XXS = 65mm, XS = 75mm, S = 85mm, M = 95mm, L = 105mm, XL = 115mm, XXL=125mm, XXXL=135mm (ASTM D6319-19) | Meets ASTM D6319-19 (All listed sizes within ± 10mm) |
| Thickness at Palm (mm) | Min 0.05 mm (ASTM D6319-19) | Meets ASTM D6319-19 (Min 0.05 mm) |
| Thickness at Finger Tip (mm) | Min 0.05 mm (ASTM D6319-19) | Meets ASTM D6319-19 (Min 0.05 mm) |
| Tensile Strength (MPa) - Before Ageing | 14min (ASTM D6319-19, ASTM D412-16(2021)) | Meets ASTM D6319-19 (14min) |
| Ultimate Elongation (%) - Before Ageing | 500min (ASTM D6319-19, ASTM D412-16(2021)) | Meets ASTM D6319-19 (500min) |
| Tensile Strength (MPa) - After Aging | 14min (ASTM D6319-19, ASTM D412-06(2021)) | Meets ASTM D6319-19 (14min) |
| Ultimate Elongation (%) - After Aging | 400min (ASTM D6319-19, ASTM D412-06(2021)) | Meets ASTM D6319-19 (400min) |
| Freedom from Pinholes | AQL 2.5 Inspection Level G-1 (ASTM D5151-19) | Meets ASTM D5151-19 |
| Residual Powder | < 2.0 mg/pc (ASTM D6124-06) | Meets ASTM D6124-06 (2022) |
| Biocompatibility - Irritation | Non-irritant (ISO 10993-23: 2021) | The test article was a non-irritant. |
| Biocompatibility - Skin Sensitization | Non-sensitizer (ISO 10993-10: 2021) | The test article was a non-sensitizer. |
| Biocompatibility - Systemic Toxicity | Not induce any acute systemic toxicity (ISO 10993-11) | Did not induce any acute systemic toxicity. |
| Resistance to Chemotherapy Drugs and Fentanyl | Defined minimum breakthrough detection times per drug (ASTM D6978-05) | Met or exceeded breakthrough times for most drugs; specific warnings for Carmustine (24.0 min) and Thiotepa (56.9 min). Fentanyl exceeded >240 minutes. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For "Freedom from Pinholes" and "Dimensions": "Per Lot Size 500,000pcs" and "ISO 2859-1 / S2/AQL 4.0" are mentioned, indicating statistical sampling methodology from production lots rather than a fixed "test set" in the AI/ML sense. Specific N values for testing each characteristic are not given but are implied by adherence to the ASTM/ISO standards.
- For "Residual Powder": "Once every PO" (Purchase Order) indicates routine testing, not a specific "test set" size.
- For Biocompatibility and Resistance to Chemotherapy Drugs/Fentanyl: The document implies standard testing procedures were followed per ISO and ASTM D6978-05. Specific sample sizes (N) for these tests are not explicitly stated within the public summary, but are defined by the referenced standards.
- Data Provenance: The manufacturer, Eco Medi Glove Sdn. Bhd., is based in Malaysia. The testing would presumably have been conducted there or by accredited labs on behalf of the manufacturer. The data is retrospective in the sense that it represents tests performed on already manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device relying on human expert consensus for ground truth. The "ground truth" here is defined by performance against objective, quantitative physical and chemical test standards (e.g., tensile strength, breakthrough time, AQL for pinholes).
4. Adjudication method for the test set
Not applicable. The "ground truth" is determined by objective laboratory measurements against defined ASTM/ISO standards, not by human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical examination glove, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical examination glove, not an AI/ML algorithm.
7. The type of ground truth used
The ground truth used consists of objective, quantitative measurements defined by international and national standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993 series, ASTM D6978-05). These standards specify the methods and acceptable ranges for physical properties (e.g., dimensions, tensile strength, elongation), chemical properties (e.g., powder residue, chemotherapy drug permeation time), and biological response (e.g., irritation, sensitization).
8. The sample size for the training set
Not applicable. This device is a physical examination glove, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical examination glove, not an AI/ML algorithm.
FDA 510(k) Clearance Letter - K233405
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.06.06
December 28, 2023
Eco Medi Glove Sdn. Bhd.
Suresh Kumar
Official Correspondent
Lot 23826, Jalan Tembaga Kuning, Kamunting Raya
Industrial Estate
Taiping, Perak Darul Ridzuan 34600
Malaysia
Re: K233405
Trade/Device Name: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
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: October 2, 2023
Received: October 5, 2023
Dear Suresh Kumar:
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.
Page 2
K233405 - Suresh Kumar Page 2
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 (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K233405 - Suresh Kumar Page 3
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K233405
Device Name
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
Indications for Use (Describe)
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs and Fentanyl Test claim
Chemotherapy Drug and Fentanyl Test Claim Concentration Minimum Breakthrough detection time in Minutes, ug/cm2/minute
- Carmustine (3.3mg/ml or 3000ppm), 24.0 minutes
- Cyclophosphamide (20mg/ml or 20,000ppm), >240 minutes
- Cisplatin (1.0mg/ml or 1,000ppm), >240 minutes
- Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), >240 minutes
- Etoposide (20mg/ml or 20,000ppm), >240 minutes
- Flourouracil (50mg/ml or 50,000), >240 minutes
- Methorexate (25mg/ml or 25,000ppm), >240 minutes
- Paclitaxel (6mg/ml or 6,000ppm), >240 minutes
- Thiotepa (10mg/ml or 10,000ppm), 56.9 minutes
- Ifosfamide (50mg/ml) >240 minutes
- Mitoxantrone (2mg/ml) , >240 minutes
- Vincristine Sulfate (1mg/ml) , >240 minutes
- Carboplatin (10.0mg/ml), >240 minutes
- Dacarbazine (DTIC) (10.0mg/ml) >240 minutes
- Mitomicin C (0.5mg/ml) >240 minutes
- Fentanyl Citrate Injection 100mg/2ml >240 minutes
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.
Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 24.0 ug/cm2/minute.
Thiotepa (10ug/ml) – Minimum Breakthrough detection time 56.9 ug/cm2/minute.
WARNING: Not for use with Carmustine and ThioTepa
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Page 5
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."
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510(K) Summary K233405
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
1.0 Submitter:
Company Name: ECO Medi Glove Sdn. Bhd.
Company Address: Lot 23826, Jalan Tembaga Kuning,
Kamunting Raya Industrial Estate,
34600 Taiping, Perak Darul Ridzuan,
Malaysia.
Contact Person: Mr. Suresh Kumar
Telephone: +605-806 2316
Fax: +605-806 2315
Email: qa1@riverstone.com.my
2.0 Preparation Date: 25th December 2023
3.0 Name of the Device
Trade Name / Proprietary Name: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
Device Name: Nitrile Patient Examination gloves.
Device Classification Name: Non-Powdered Patient Examination gloves (21 CFR 880.6250). Device Class: Class I.
Product Code: LZA, LZC, OPJ, and QDO
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4.0 Identification of The Legally Marketed Device:
Predicate Device: K171339, EMG Blue Nitrile Examination Glove Powder Free with Chemotherapy Drugs.
5.0 Device Description
The subject device in this 510(k) Notification is EMG Blue Powder Free Nitrile Examination Gloves with Chemotherapy Drugs and Fentanyl Test Claim. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl test claims.
The Blue Nitrile Medical Examination Gloves, Powder Free, is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner (product Code LZA) and are used with chemotherapy drugs (Product code LZC and OPJ) and fentanyl test (Product code QDO).
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6.0 Intended Use/Indications for Use
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim 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. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs and Fentanyl Test claim.
| # | Chemotherapy Drug and Fentanyl Test Claim Concentration | Minimum Breakthrough detection time in Minutes, ug/cm²/minute |
|---|---|---|
| 1 | Carboplatin (10mg/ml or 10,000ppm) | >240 minutes |
| 2 | Carmustine (3.3mg/ml or 3000ppm), | 24.0 minutes |
| 3 | Cisplatin (1.0mg/ml or 1,000ppm), | >240 minutes |
| 4 | Cyclophosphamide (20mg/ml or 20,000ppm), | >240 minutes |
| 5 | Dacarbazine (DTIC) (10.0mg/ml) | >240 minutes |
| 6 | Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), | >240 minutes |
| 7 | Etoposide (20mg/ml or 20,000ppm), | >240 minutes |
| 8 | Fluorouracil (50mg/ml or 50,000), | >240 minutes |
| 9 | Ifosfamide (50mg/ml) | >240 minutes |
| 10 | Methorexate (25mg/ml or 25,000ppm), | >240 minutes |
| 11 | Mitomycin (0.5mg/ml or 500ppm) | >240 minutes |
| 12 | Mitoxantrone (2mg/ml or 2,000ppm) , | >240 minutes |
| 13 | Paclitaxel (6mg/ml or 6,000ppm), | >240 minutes |
| 14 | Thiotepa (10mg/ml or 10,000ppm), | 56.9 minutes |
| 15 | Vincristine Sulfate (1mg/ml) , | >240 minutes |
| 16 | Fentanyl Citrate Injection 100mg/2ml | >240 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.
Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 24.0 ug/cm2/minute.
Thiotepa (10ug/ml) – Minimum Breakthrough detection time 56.9 ug/cm²/minute.
WARNING: Not for use with Carmustine and ThioTepa
Page 9
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7.0 Specification for the subject Nitrile gloves:
7.1 Dimension and Thickness of Gloves
| Dimension | Size XXS | Size XS | Size S | Size M | Size L | Size XL | Size XXL | Size XXXL |
|---|---|---|---|---|---|---|---|---|
| Overall Length (mm) | 230min | 230min | 230min | 230min | 230min | 230min | 230min | 230min |
| Width (± 10mm) | 65 | 75 | 85 | 95 | 105 | 115 | 125 | 135 |
| Thickness at Palm (mm) | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min |
| Thickness at Finger Tip (mm) | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min |
7.2 Gloves Physical Properties and Holes
| Measurement | Before Ageing | After Aging at 70°C for 168 hrs @ 100°C for 22 hrs |
|---|---|---|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5 Inspection Level G-1 | AQL 2.5 Inspection Level G-1 |
Gloves meet all the specifications listed in ASTM D 6319-19
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Technological Characteristics Comparison of the Proposed and Predicate Devices
| Characteristics | Acceptance Criteria | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim K233405 | Predicate Device EMG Blue Nitrile Examination Glove Powder-Free with Chemotherapy Drugs K171339 | Assessment Similarities and Differences |
|---|---|---|---|---|
| Product Code | LZA, LZC , OPJ, and QDO | LZA, LZC | Similar | |
| Intended use/Indications for Use | A powder-free 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. The device is for over-the-counter use. | A powder-free 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. The device is for over-the-counter use. | same | |
| Material use | Nitrile compound | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Same | |
| Sterility | Non sterile | Non sterile | Same | |
| Surface | Finger Textured | Finger Textured | Same | |
| Cuffing Beading | Rolled Beading | Rolled Beading | Same | |
| Design | Ambidextrous | Ambidextrous | Same | |
| Dimensions | Overall Length (mm) Min 230mm Width (± 10mm) Size XXS = 65mm Size XS = 75mm Size S = 85mm Size M = 95mm Size L = 105mm Size XL = 115mm Size XXL=125mm Size XXXL=135mm Thickness at Palm (mm) Min; 0.05 mm Thickness at Finger Tip (mm) Min 0.05 mm | Overall Length (mm) Min 230mm Width (± 10mm) Size XXS = 65mm Size XS = 75mm Size S = 85mm Size M = 95mm Size L = 105mm Size XL = 115mm Size XXL=125mm Size XXXL=135mm Thickness at Palm (mm) Min; 0.05 mm Thickness at Finger Tip (mm) Min 0.05 mm | Overall Length (mm) Min 230 mm Width (± 5mm) Size S = 85mm Size M = 95mm Size L = 105mm Size XL = 115mm Thickness at Palm (mm) Min; 0.05 mm Thickness at Finger Tip (mm) Min 0.05 mm | Similar additional sizes were added to the subject device |
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| Characteristics | Acceptance Criteria | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim, | Predicate Device EMG Blue Nitrile Examination Glove Powder-Free with Chemotherapy Drugs K171339 | Assessment Similarities and Differences |
|---|---|---|---|---|
| Physical properties | Before Ageing Tensile Strength (MPa) = 14min Ultimate Elongation (%) = 500min After Aging at 70°C for 168 hrs @ 100°C for 22 hrs Tensile Strength (MPa) = 14min Ultimate Elongation (%) = 400min | Meets ASTM D6319-19 | Meets ASTM D6319-19 | same |
| Freedom from pinholes | AQL 2.5 Inspection Level G-1 | Meets ASTM D5151-19 | Meets ASTM D5151-19 | same |
| Residual Powder | < 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 | same |
| Biocompatibility | ISO 10993-23: 2021 Biological evaluation of medical devices- Part 23: Test for irritation | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | same |
| ISO 10993-10: 2021 Biological Evaluation on Medical Device – Part 10: Test for Skin Sensitization | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. | same | |
| ISO 10993-11 Biological evaluation on medical device Part 11 – Test for systemic toxicity | Under the conditions of this study, not induce any acute systemic toxicity | Under the conditions of this study, not induce any acute systemic toxicity | Same |
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| Characteristics | Acceptance Criteria | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim, | Predicate Device EMG Blue Nitrile Examination Glove Powder-Free with Chemotherapy Drugs K171339 | Assessment Similarities and Differences |
|---|---|---|---|---|
| Resistance against Chemotherapy Drugs | Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugs ASM D6978-05 | 1) Carboplatin (10mg/ml or 10,000ppm) >240 minutes 2) Carmustine (3.3mg/ml or 3000ppm), 24.0 minutes 3) Cisplatin (1.0mg/ml or 1,000ppm), >240 minutes 4) Cyclophosphamide (20mg/ml or 20,000ppm), >240 minutes 5) Dacarbazine (DTIC) (10.0mg/ml) >240 minutes 6) Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), >240 minutes 7) Etoposide (20mg/ml or 20,000ppm), >240 minutes 8) Fluorouracil (50mg/ml or 50,000), >240 minutes 9) Ifosfamide (50mg/ml) >240 minutes 10) Methorexate (25mg/ml or 25,000ppm), >240 minutes 11) Mitomicin (0.5mg/ml or 500ppm) >240 minutes 12) Mitoxantrone (2mg/ml or 2,000ppm) , >240 minutes 13) Paclitaxel (6mg/ml or 6,000ppm), >240 minutes 14) Thiotepa (10mg/ml or 10,000ppm), 56.9 minutes 15) Vincristine Sulfate (1mg/ml) , >240 minutes 16) Fentanyl Citrate Injection 100mg/2ml >240 minutes Warning : Not for use with Carmustine or Thio Tepa | 1) Carmustine (BCNU) 3.3mg/ml 24.0 minutes 2) Cisplatin 1.0mg/mL, >240 minutes 3) Cyclophosphamide (Cytoxan) (20mg/ml) >240 minutes 4) Dacarbazine (10mg/ml) >240 minutes 5) Doxorubicin HCI (2.0mg/ml) >240 minutes 6) Etoposide (20.0mg/ml >240 minutes 7) Fluorouracil (50.0mg/ml) >240 minutes 8) Methotrexate (25mg/ml) >240 minutes 9) Paclitaxel (6.0mg/ml) >240 minutes 10) ThioTepa (10.0mg/ml) 56.9 minutes 11) Vincristine Sulfate 1.0mg/ml, >240 minutes 12) Ifosfamide (50mg/ml) 13) Mitoxantrone (2mg/ml or 2,000ppm) , 14) Carboplatin (10mg/ml or 10,000ppm) 15) Vincristine Sulfate (1mg/ml) , Warning : Not for use with Carmustine or Thio Tepa | Similar. Additional Fentanyl test is conducted for Device sample |
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| Characteristics | Acceptance Criteria | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim, | Predicate Device EMG Blue Nitrile Examination Glove Powder-Free with Chemotherapy Drugs K171339 | Assessment Similarities and Differences |
|---|---|---|---|---|
| Resistance against Chemotherapy Drugs | Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugs ASM D6978-05 | 1) Carboplatin (10mg/ml or 10,000ppm) >240 minutes 2) Carmustine (3.3mg/ml or 3000ppm), 24.0 minutes 3) Cisplatin (1.0mg/ml or 1,000ppm), >240 minutes 4) Cyclophosphamide (20mg/ml or 20,000ppm), >240 minutes 5) Dacarbazine (DTIC) (10.0mg/ml) >240 minutes 6) Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), >240 minutes 7) Etoposide (20mg/ml or 20,000ppm), >240 minutes 8) Fluorouracil (50mg/ml or 50,000), >240 minutes 9) Ifosfamide (50mg/ml) >240 minutes 10) Methorexate (25mg/ml or 25,000ppm), >240 minutes 11) Mitomicin (0.5mg/ml or 500ppm) >240 minutes 12) Mitoxantrone (2mg/ml or 2,000ppm) , >240 minutes 13) Paclitaxel (6mg/ml or 6,000ppm), >240 minutes 14) Thiotepa (10mg/ml or 10,000ppm), 56.9 minutes 15) Vincristine Sulfate (1mg/ml) , >240 minutes 16) Fentanyl Citrate Injection 100mg/2ml >240 minutes Warning : Not for use with Carmustine or Thio Tepa | 1) Carmustine (BCNU) 3.3mg/ml 24.0 minutes 2) Cisplatin 1.0mg/mL, >240 minutes 3) Cyclophosphamide (Cytoxan) (20mg/ml) >240 minutes 4) Dacarbazine (10mg/ml) >240 minutes 5) Doxorubicin HCI (2.0mg/ml) >240 minutes 6) Etoposide (20.0mg/ml >240 minutes 7) Fluorouracil (50.0mg/ml) >240 minutes 8) Methotrexate (25mg/ml) >240 minutes 9) Paclitaxel (6.0mg/ml) >240 minutes 10) ThioTepa (10.0mg/ml) 56.9 minutes 11) Vincristine Sulfate 1.0mg/ml, >240 minutes 12) Ifosfamide (50mg/ml) 13) Mitoxantrone (2mg/ml or 2,000ppm) , 14) Carboplatin (10mg/ml or 10,000ppm) 15) Vincristine Sulfate (1mg/ml) , Warning : Not for use with Carmustine or Thio Tepa | Similar. Additional Fentanyl test is conducted for Device sample |
Warning : Not for use with Carmustine or Thio Tepa
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8.0 Summary of Non-Clinical Performance test data
| Characteristics | Test Standard | Acceptance Criteria | Test Result | Remark |
|---|---|---|---|---|
| Freedom from Pin holes | ASTM D5151 -19 (Re-approved 2011) | AQL 2.5 Inspection Level G-1 | Meets ASTM D5151-19 | Per Lot Size 500,000pcs |
| Dimensions | ASTM D6319 -19 | Length Min 230mm | Meets ASTM D6319-19 | Lot Size 500,000pcs |
| ASTM D6319 -19 | Width Size XXS = 65mm±10 Size XS = 75mm±10 Size S = 85mm±10 Size M = 95mm±10 Size L = 105mm±10 Size XL = 115mm±10 SizeXXL =125mm±10 Size XXXL = 135mm±10 | ISO 2859-1 / S2/AQL 4.0 | ||
| ASTM D6319 -19 | Thickness at Palm (mm) Min; 0.05 mm Thickness at Finger Tip (mm) Min 0.05 mm | ISO 2859-1 / S2/AQL 4.0 | ||
| Physical properties | ASTM D6319 -19 ASTM D412-16(2021) | Before Ageing Tensile Strength (MPa) = 14min Ultimate Elongation (%) = 500min | Meets ASTM D6319-19 | |
| ASTM D6319 -19 and ASTM D412-06(2021) | After Aging at 70°C for 168 hrs @ 100°C for 22 hrs Tensile Strength (MPa) = 14min Ultimate Elongation (%) = 400min | |||
| Powder-free residue | ASTM D6124-06 | < 2.0 mg/pc | Meets ASTM D6124-06 (2022) | Once every PO |
| Biocompatibility | ISO 10993-23: 2021 Biological evaluation of medical devices- Part 23: Test for irritation | The Device shall be non-irritant. | Under the conditions of this study, the test article was a non-irritant | As per Device with same color |
| ISO 10993-10: 2021 Biological Evaluation on Medical Device – Part 10: Test for Skin Sensitization | The device shall be non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. | As per Device with same color | |
| ISO 10993-11 Biological evaluation on medical device Part 11 – Test for systemic toxicity | The device shall not induce any acute systemic toxicity | Under the conditions of this study, not induce any acute systemic toxicity | As per Device with same color |
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Summary of Clinical Testing: Not applicable.
9.0 Conclusion
The Conclusion drawn from the non-Clinical test demonstrates that the subject device in 510(K) Submission, Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K171339.
§ 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.