(280 days)
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
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color is added) and are powder free.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Dimension | ASTM D3578-19 | Length | Min 230 mm for all sizes | Small: 240 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 241 mm (All Pass) |
| Width | Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 111 ± 10 mm, Extra Large: 120 ± 10 mm | Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm (All Pass) | ||
| Thickness (Palm) | 0.08 mm min for all sizes | Small: 0.09 mm, Medium: 0.09 mm, Large: 0.10 mm, Extra Large: 0.09 mm (All Pass) | ||
| Thickness (Finger) | 0.08 mm min for all sizes | Small: 0.12 mm, Medium: 0.12 mm, Large: 0.13 mm, Extra Large: 0.12 mm (All Pass) | ||
| Physical Properties | ASTM D3578-19 | Tensile Strength (Before Aging) | 18 MPa Minimal for all sizes | Small: 18.04 MPa, Medium: 19.13 MPa, Large: 18.26 MPa, Extra Large: 18.64 MPa (All Pass) |
| Tensile Strength (After Aging) | 14 MPa Minimal for all sizes | Small: 15.02 MPa, Medium: 18.12 MPa, Large: 16.01 MPa, Extra Large: 15.06 MPa (All Pass) | ||
| Ultimate Elongation (Before Aging) | 650% Min for all sizes | Small: 651%, Medium: 654%, Large: 650%, Extra Large: 650% (All Pass) | ||
| Ultimate Elongation (After Aging) | 500% Min for all sizes | Small: 501%, Medium: 601%, Large: 501%, Extra Large: 502% (All Pass) | ||
| Watertight Test | ASTM D5151-19 | Detection of Holes | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8 | Small: 0, Medium: 0, Large: 0, Extra Large: 0 (All Pass) |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | Residual powder in gloves | 2 mg per glove or less | Small: 0.62 mg/glove, Medium: 0.46 mg/glove, Large: 0.61 mg/glove, Extra Large: 0.61 mg/glove (All Pass) |
| Protein Content | ASTM D5712-15 | Extractable protein in natural rubber | Less than 200 µg/dm² | Small: 124.36 µg/dm², Medium: 140.78 µg/dm², Large: 134.26 µg/dm², Extra Large: 159.46 µg/dm² (All Pass) |
| Biocompatibility | ISO 10993-10 | Primary Skin Irritation | Not a primary skin irritant | Not a primary skin irritant under the conditions of the study (Pass) |
| Dermal Sensitization | Not a contact sensitizer | Not a contact sensitizer under the conditions of the study (Pass) | ||
| ISO 10993-5 | In vitro cytotoxicity | No data available for predicate (Tested for subject device) | Cytotoxic for undiluted and 1:2 dilutions, non-cytotoxic for 1:4, 1:8, 1:16, 1:32 dilutions for subject device (Different from predicate, but indicates testing) | |
| ISO 10993-11 | Acute Systemic Toxicity | No data available for predicate (Tested for subject device) | Did not induce any systemic toxicity for subject device (Different from predicate, but indicates testing) |
2. Sample Size Used for the Test Set and Data Provenance
- Dimension Tests: While specific sample sizes for each dimension measurement aren't individually listed, the watertight test indicates a sample size of 200 pieces for that particular test. For residual powder, the sample size was 5 pieces. For protein content, the sample size was 3 pieces.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that the manufacturer is Bestsafe Glove Co., LTD. based in Thailand, it is highly likely that the testing was conducted in Thailand or by laboratories compliant with international standards on behalf of the manufacturer. The tests are presented as part of a 510(k) submission, typically involving tests specifically conducted for the device seeking clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the document describes performance testing for medical gloves against established ASTM and ISO standards, not a diagnostic or AI-driven device requiring human expert ground truth for image interpretation or similar tasks. The "ground truth" here is defined by the objective measurement criteria within the specified standards.
4. Adjudication Method for the Test Set
- This information is not applicable for the same reasons as point 3. The testing involves objective measurements against established numerical and qualitative criteria defined by the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This information is not applicable. The device is a physical medical glove, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance comparison was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device is a physical medical glove, not a software or AI-based device.
7. The Type of Ground Truth Used
- The ground truth for the performance of the gloves is established through objective measurements against predefined criteria and thresholds set by international standards for medical gloves, specifically:
- ASTM D3578-19 (Standard Specification for Rubber Examination Gloves)
- 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 D5712-15 (Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
8. The Sample Size for the Training Set
- This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
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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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 5, 2021
Bestsafe Glove CO., LTD. Piyawat Chirasakulkarun Chief Executive Officer 52/43 Wat Khot Hin-Khao Phai Road, T. Tubma Muang Rayong, Rayong 21000 Thailand
Re: K210253
Trade/Device Name: Best Glove-Latex Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYY Dated: May 25, 2021 Received: August 30, 2021
Dear Piyawat Chirasakulkarun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K210253
Device Name
BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE
Indications for Use (Describe)
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
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.
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 PRA Staff@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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Image /page/3/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below the word "BESTSAFE" is the company name "BESTSAFE GLOVE CO., LTD" in smaller blue letters. There is a registered trademark symbol in the upper right corner of the logo.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000 TAX ID:0215563006105 TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 EMAIL : SALES@BESTSAFE.CO.TH WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM
510(k) SUMMARY K210253 Latex Powder Free Examination Glove
1.0 Applicant Information
| Applicant: | BESTSAFE GLOVE CO., LTD | |
|---|---|---|
| Address | 52/43 Watkodhin-Kaophai Rd. T. Tubma,A. Muang Rayong Rayong. THAILAND 21000 | |
| Phone Number: | +66 (038)-949880 | |
| Fax Number: | +66 (038)-949850 | |
| Name of Contact Person: | Piyawat Chirasakulkarun | |
| Contact Number: | +66 81 4022099 | |
| Contact Email: | sales@bestsafe.co.th | |
| Preparation date: | September 6, 2021 | |
| 2.0 | Device Identification: | |
| Trade/Proprietary Name(s): | BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE | |
| Common Name: | Latex Powder Free Examination Gloves | |
| Classification Name: | Patient Examination Gloves | |
| 510(k): | K210253 | |
| Device Class: | I | |
| Product Code: | LYY | |
| Registration Number | 21 CFR 880.6250 | |
| Review Panel | General Hospital | |
| 3.0 | Predicate Device | |
| Device Name: | MPXX™ Powder Free Natural Rubber Latex Examination Gloves | |
| Manufacturer: | Total Glove Company Sdn. Bhd. | |
| 510(k): | K110250 | |
| Device Class: | I | |
| Product Code: | LYY |
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Image /page/4/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue with a plus sign in the middle. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in a smaller font size. There is a registered trademark symbol in the upper right corner of the logo.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, AMUANG, RAYONG, RAYONG. THAILAND 21000 TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TAX ID:0215563006105 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 EMAIL : SALES@BESTSAFE.CO.TH WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM
4.0 Description of the Device:
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color is added) and are powder free.
5.0 Indication for Use of the Device:
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
6.0 Comparison of Technological characteristics between predicate and subject devices
| Characteristics | References/Standards | Device performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| 510(k) Number | - | K110250 | K210253 | --- |
| Manufacturer(s) | - | Total Glove Company Sdn.Bhd. | BESTSAFE GLOVE CO.,LTD | --- |
| Name of device | - | MPXX TM Powder Free NaturalRubber Latex ExaminationGloves | BEST GLOVE -LATEXPOWDER FREEEXAMINATION GLOVE | --- |
| Indication for Use | Medical GlovesGuidance Manual,Issued on January 22,2008 | MPXX TM Powder Free NaturalRubber Latex ExaminationGloves are single use deviceintended for medical purposesthat is worn on the hand ofhealthcare and similarpersonnel to preventcontamination betweenhealthcare and the patient. | A powder-free patientExamination Glove is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner | Same |
| Material | ASTM D3578-19 | Natural Rubber Latex | Natural Rubber Latex | Identical |
| Color | Natural Colo | Natural Colo | Same | |
| Size | Medical GloveGuidance Manual-Labeling- Issued onJanuary 22, 2008 | Extra SmallSmallMediumLargeExtra Large | SmallMediumLargeExtra Large | Different |
| Characteristics | References/Standards | Device performance | Comparison | |
| Single Use | Medical GlovesGuidance Manual -Issued on January 22,2008 | Single use | Single use | Same |
| Sterile/Non-sterile | - | Non-sterile | Non-sterile | Same |
| Dimension | ASTM D3578-19 | Length230 mm minimum | Length230 mm min | Similar |
| Size | Actual value | |||
| Small | 240 | |||
| Medium | 240 | |||
| Large | 240 | |||
| Extra Large | 241 | |||
| WidthMedium: 95 mm ± 10 mm(for Medium size) | Different | |||
| Size | Actual value | |||
| Small | 85 | |||
| Medium | 93 | |||
| Large | 105 | |||
| Extra Large | 115 | |||
| Thickness | ASTM D3578-19 | Finger = 0.08 mm. minPalm = 0.08 mm. Min | Finger = 0.08 mm. minPalm = 0.08 mm. Min | Similar |
| Size | Palm(Actual value) | Finger(Actual value) | ||
| Small | 0.09 | 0.12 | ||
| Medium | 0.09 | 0.12 | ||
| Large | 0.10 | 0.13 | ||
| Extra Large | 0.09 | 0.12 |
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Image /page/5/Picture/0 description: The image shows the logo for BESTSAFE. On the left is a blue hand. To the right of the hand is the word "BESTSAFE" in blue, with a plus sign in the upper left corner of the word. Below the word "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" in a smaller font.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000 TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TAX ID:0215563006105 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558
WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH
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Image /page/6/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side. To the right of the hand is the word "BESTSAFE" in blue, with a plus sign incorporated into the "B". Below "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" also in blue.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000 TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TAX ID:0215563006105 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH
| Characteristics | References/Standards | Device performance | Comparison | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate | Current | ||||||||||||||||||
| Physical Properties | ASTM D3578-19 | Before AgingTensile Strength18 MPa minAfter AgingTensile Strength14 MPa min | Before AgingTensile Strength (18 MPa min) Size Actual value Small 18.04 Medium 19.13 Large 18.26 Extra Large 18.64 | Similar | |||||||||||||||
| Characteristics | References/Standards | Device performance | Comparison | ||||||||||||||||
| Predicate | Current | ||||||||||||||||||
| Water Tight Test(1000 ml) | ASTM D5151 – 19 | Pass AQL 1.5 | After AgingTensile Strength (14 MPa min) Size Actual value Small 15.02 Medium 18.12 Large 16.01 Extra Large 15.06 | Pass AQL 1.5 | Same | Similar | |||||||||||||
| Powder Residual | ASTM D6124-06(Reapproved 2017) | Meet $≤$ 2.0 mg/glove | $≤$ 2.0 mg/glove | Similar | |||||||||||||||
| Size Residual powder content (mg/glove) Small 0.62 Medium 0.46 Large 0.61 Extra Large 0.61 | |||||||||||||||||||
| Before AgingUltimate Elongation650% minAfter AgingUltimate Elongation500% min (after aging) | Before AgingUltimate Elongation : 650% min Size Actual value Small 651 Medium 654 Large 650 Extra Large 650 | Similar | |||||||||||||||||
| Biocompatibility | Primary Skin Irritation -ISO 10993-10 ThirdEdition 2010-08-01 | Not a primary skin irritant under the conditions of the study | Not a primary skin irritant under the conditions of the study | Same | |||||||||||||||
| Dermal Sensitization -ISO 10993-10 ThirdEdition 2010-08-01 | Not a contact sensitizer under the conditions of the study | Not a contact sensitizer under the conditions of the study | Same | ||||||||||||||||
| In vitro cytotoxicityISO10993-5 :2009(E) | No data is available | Under the conditions of the study cytotoxic for undiluted (neat) and 1:2 dilutions but noncytotoxic for 1:4, 1:8, 1:16 and 1:32 dilutions. Moreover, under the conditions of the study, non acute systemic toxic. | Different | ||||||||||||||||
| Acute Systemic ToxicityISO10993-11:2017(E) | No data is available | Under the conditions of the study, did not induce any systemic toxicity. | Different | ||||||||||||||||
| After AgingUltimate Elongation : 500% min Size Actual value Small 501 Medium 601 Large 501 Extra Large 502 | Similar |
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Image /page/7/Picture/0 description: The image contains the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue with a white cross in the middle of the "B". Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in a smaller font size. There is a registered trademark symbol in the upper right corner of the logo.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000 TAX ID:0215563006105 TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558
WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH
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Image /page/8/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" also in blue. There is a registered trademark symbol in the upper right corner of the logo.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000
TAX ID:0215563006105 TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558
WEBSITE : WWW.BESTSAFE.CO.TH | WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH
7.0 Summary of Non-clinical performance Tests
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D3578-19Standard Specification for RubberExamination Gloves | To determine the lengthof the gloves | Min 230 mm for all sizes | Small: 240 mmMedium: 240 mmLarge: 240 mmExtra Large: 241 mm | Pass |
| ASTM D3578-19Standard Specification for RubberExamination Gloves | To determine the widthof the gloves | Small: 80 ± 10 mmMedium: 95±10mmLarge: 111± 10 mmExtra Large: 120 ± 10 mm | Small: 85 mmMedium: 93 mmLarge: 105 mmExtra Large: 115 mm | Pass | |
| ASTM D3578-19Standard Specification for RubberExamination Gloves | To determine thethickness of the gloves | Palm 0.08 mm minFinger 0.08 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.12 mmMedium: Palm: 0.09 mm, Finger: 0.12 mmLarge: Palm 0.10 mm, Finger: 0.13 mmExtra Large: Palm 0.09 mm, Finger: 0.12 mm | Pass | |
| PhysicalProperties | ASTM D3578-19Standard Specification for RubberExamination Gloves | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength 18MpaMinimal for all sizesAfter Ageing TensileStrength 14MpaMinimal for all sizes | Before AgeingSmall: 18.04 MPaMedium: 19.13 MPaLarge: 18.26 MPaExtra Large: 18.64 MPaAfter ageing:Small: 15.02 MPaMedium: 18.12 MPaLarge: 16.01 MPaExtra Large: 15.06 MPa | Pass |
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Image /page/9/Picture/0 description: The image contains the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in large, bold, blue letters. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" in smaller, blue letters. There is a registered trademark symbol in the upper right corner of the logo.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, THAILAND 21000
TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 TAX ID:0215563006105
WEBSITE : WWW.BESTSAFE.CO.TH | WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|---|---|---|---|---|---|
| PhysicalProperties | ASTM D3578-19Standard Specification for RubberExamination Gloves | To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation650% Min for all sizesAfter Ageing UltimateElongation 500% Minfor all sizes | Before AgeingSmall: 651%Medium: 654 %Large:650%Extra Large:650%After ageing:Small:501%Medium: 601%Large:501%Extra Large:502% | Pass |
| Watertight test | ASTM D5151-19Standard Test Method for Detectionof Holes in MedicalGloves | To determine the holes inthe gloves | Sample size: 200 pcsInspection level : GlAQL 1.5Acceptance Number 7Rejection Number 8 | The batch size for this sampling is 35,001-150,000. Hence, according to the singlesampling plan GI, the sample to be drawnis under code L equivalent to 200 pcs withaccept 7 and reject 8 to be accept underAQL 1.5.Small: 0 (Zero)Medium: 0 (Zero)Large:0 (Zero)Extra Large:0 (Zero) | Pass |
| Residualpowder | ASTM D6124-06 (Reapproved 2017)Standard Test Method for ResidualPowder on Medical Gloves | To determine the residualpowder in the gloves | 2 mg per glove or less | Sample size : 5 pcsRequirement: 2 mg per glove or lessResultSmall:0.62 mg/gloveMedium: 0.46 mg/gloveLarge: 0.61 mg/gloveExtra Large:0.61 mg/glove | Pass |
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Image /page/10/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in a smaller font, also in blue. There is a registered trademark symbol in the upper right corner of the logo.
52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, AMUANG, RAYONG, RAYONG. THAILAND 21000
TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TAX ID : 0215563006105 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 EMAIL : SALES@BESTSAFE.CO.TH WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM
Status Test Method Standard Acceptance Criteria Purpose of testing Result Protein content ASTM D5712 - 15, Standard Test Less than 200 µg/dm² Pass To determine the Sample size : 3 pcs extractable protein in Method for Analysis of Aqueous Requirement: Less than 200 µg/dm2 Extractable Protein in Natural the gloves Result Small:124.36 ug /dm2 Rubber. Medium: 140.78 µg /dm² Large: 134.26 µg /dm² Extra 159.46 µg /dm²
The performance test data of the non-clinical tests meet following standards:
ASTM D 3578 – 19 Standard Specification for Rubber Examination Gloves
ASTM D 5151-19: 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 D5712 - 15, Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber.
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Image /page/11/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in a smaller font size.
BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โกลฟ จำกัด 52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, AMUANG, RAYONG, RAYONG. THAILAND 21000 TEL OFFICE : 038-949877-79 FAX : (+66)038-694493, 038-949899 TAX ID:0215563006105 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 EMAIL : SALES@BESTSAFE.CO.TH WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM
8.0 Summary of Clinical Performance Tests:
Not Applicable
9.0 Conclusion:
The conclusion drawn from the non-clinical tests demonstrates that the subject device Latex Examination Powder Free Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K110250
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§ 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.