(269 days)
Best Glove - Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided document describes the acceptance criteria and performance of the BEST GLOVE -NITRILE POWDER FREE EXAMINATION GLOVE as determined through non-clinical testing. It does not involve AI or algorithms, so most of the requested information about studies involving expert Ground Truth, MRMC studies, or multi-reader studies is not applicable.
Here's the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method & Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|
| Dimension (ASTM D6319-19) | |||
| Length | Min 230 mm for all sizes | Small: 243 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 240 mm | Pass |
| Width | Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, Extra Large: 120 ± 10 mm | Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm | Pass |
| Thickness (Palm & Finger) | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mm; Medium: Palm: 0.06 mm, Finger: 0.08 mm; Large: Palm 0.09 mm, Finger: 0.12 mm; Extra Large: Palm 0.09 mm, Finger: 0.12 mm | Pass |
| Watertight test (ASTM D5151-19) | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8 | Small: 0 (Zero), Medium: 0 (Zero), Large: 0 (Zero), Extra Large: 0 (Zero) defects. (The batch size for this sampling is 35,001-150,000, under code L equivalent to 200 pcs with accept 7 and reject 8 to be accept under AQL 1.5) | Pass |
| Residual powder (ASTM D6124-06, Reapproved 2017) | 2 mg per glove or less | Small: 1.42 mg/glove, Medium: 0.50 mg/glove, Large: 1.34 mg/glove, Extra Large: 1.36 mg/glove | Pass |
| Physical Properties - Tensile Strength (ASTM D6319-19) | Before Ageing: 14 MPa minimal for all sizes; After Ageing: 14 MPa minimal for all sizes | Before Ageing: Small: 18.37 MPa, Medium: 30.62 MPa, Large: 18.30 MPa, Extra Large: 18.20 MPa; After Ageing: Small: 14.08 MPa, Medium: 31.89 MPa, Large: 14.00 MPa, Extra Large: 14.00 MPa | Pass |
| Physical Properties - Ultimate Elongation (ASTM D6319-19) | Before Ageing: 500% Min for all sizes; After Ageing: 400% Min for all sizes | Before Ageing: Small: 612%, Medium: 500%, Large: 620%, Extra Large: 587%; After Ageing: Small: 408%, Medium: 499%, Large: 403%, Extra Large: 416% | Pass |
| Biocompatibility: Primary Skin Irritation (ISO 10993-10) | Not an irritant | Under the conditions of the study, not an irritant | Same |
| Biocompatibility: Dermal Sensitization (ISO 10993-10) | Not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility: In vitro cytotoxicity (ISO10993-5) | Non-cytotoxic | Under the conditions of the study cytotoxic for undiluted (neat) and 1:2 dilutions but non-cytotoxic for 1:4, 1:8 and 1:16 dilutions. Moreover, under the conditions of the study, did not induce any systemic toxicity. (This is a "Similar" comparison to the predicate, implying acceptance for the device) | Similar |
| Biocompatibility: Acute Systemic Toxicity (ISO10993-11) | Extracts do not pose a systemic toxicity | Under the conditions of the study, did not induce any systemic toxicity. | Same |
2. Sample Size Used for the Test Set and Data Provenance
- Dimension, Thickness, Physical Properties (Tensile Strength, Ultimate Elongation): The sample sizes for these tests are not explicitly stated in the table, but the results are given for different sizes (Small, Medium, Large, Extra Large) of the gloves. The tests were performed against specified ASTM standards (ASTM D6319-19).
- Watertight Test: A sample size of 200 pieces was used for the watertight test for each size, following a single sampling plan code L for a batch size of 35,001-150,000.
- Residual Powder: A sample size of 5 pieces was used for the residual powder test for each size.
- Biocompatibility Tests: The document states "Under the conditions of the study" for these tests, implying specific samples were used for the in-vitro and in-vivo (animal) tests, but exact numbers of samples/animals are not provided in this summary.
- Data Provenance: The document is a 510(k) Premarket Notification from Thailand (Bestsafe Glove Co., LTD is based in Rayong, Thailand), indicating the tests were likely conducted in or overseen by the manufacturer in Thailand, in accordance with international standards (ASTM, ISO). The studies are non-clinical (laboratory/material testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The document describes material property tests and biocompatibility tests for medical gloves, not a diagnostic device involving expert interpretation or "ground truth" established by experts in a clinical context. The "ground truth" for these tests is defined by the objective measurement criteria within the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as these are objective performance measurements against established standards for physical and chemical properties of gloves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a medical glove, not an imaging or diagnostic AI tool. Therefore, no MRMC study was performed or is relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device (glove), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for these tests are the objective measurement criteria defined by the specified international standards:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, thickness, physical properties).
- ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves (for watertight test).
- ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for primary skin irritation and dermal sensitization).
- ISO 10993-5:2009(E): Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-11:2017(E): Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process for gloves is subject to quality control and batch testing, which can be seen as ongoing verification of product consistency, but not "training data" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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 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.
October 25, 2021
Bestsafe Glove CO., LTD Piyawat Chirasakulkarun Chief Executive Officer 52/43 Wat Khot Hin-Khao Phai Road, Tubma Muang Rayong, Rayong 21000 Thailand
Re: K210249
Trade/Device Name: Best Glove-Nitrile Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 30, 2021 Received: September 24, 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 (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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210249
Device Name BEST GLOVE -NITRILE POWDER FREE EXAMINATION GLOVE
Indications for Use (Describe)
Best Glove - Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
| 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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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 text "BESTSAFE GLOVE CO., LTD" in a smaller font size, also in blue. There is a registered trademark symbol in the upper right corner of the logo.
BESTSAFE GLOVE CO.,LTD. I บริษัท เบสท์เซฟ
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
510(k) SUMMARY K210249 Nitrile Powder Free Examination Gloves
1.0 Submitter:
| Applicant: | BESTSAFE GLOVE CO., LTD52/43 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 | |
| Preparation date: | July 30, 2021 |
2.0 Identification of the subjected device:
| Trade/Proprietary Name(s): | BEST GLOVE -NITRILE POWDER FREE EXAMINATION GLOVE |
|---|---|
| Common Name: | Nitrile Powder Free Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product code | LZA |
| Regulation Number: | 21 CFR 880.6250 |
3.0 Predicate Device:
| Device Name: | Palm Care Blue Nitrile Examination Gloves Powder Free |
|---|---|
| 510(k): | K202384 |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |
4.0 Description of the Device:
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
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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, 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.
5.0 Indication for Use:
Best Glove Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device:
| Characteristics | Standards | Device performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| 510(k) Number | - | K202384 | K210249 | ---- |
| Manufacturer(s) | - | Hi-Care Thai Gloves Co.Ltd | BESTSAFE GLOVE CO.,LTD | ---- |
| Indication for Use | Medical GlovesGuidance Manual -Issued on January22, 2008 | A powder-free patient Examination Gloves 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 | Best Glove Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Similar |
| Material | ASTM D6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Textured | Finger Textured | Same |
| Size | ASTM D6319-19 | Extra SmallSmallMediumLargeExtra Large | SmallMediumLargeExtra Large | Different |
| Single Use | Medical GlovesGuidance Manual -Issued on January22, 2008 | Single use | Single use | Same |
| Dimension | ASTM D6319-19 | Length 230 mm min.Width 95 ± 10 mm min(for Medium size) | Length 230 mm minWidth 95 ± 10 mm min(for Medium size) | Same |
| Standards | Device performance | |||
| Characteristics | Predicate | Current | Comparison | |
| Thickness | ASTM D6319-19 | Finger: 0.05 mm minPalm: 0.05 mm min | Finger: 0.05 mm minPalm: 0.05 mm min | Same |
| PhysicalProperties | ASTM D6319-19 | Before agingTensile Strength:14 MPa minUltimate Elongation:500% minAfter agingTensile Strength14 MPa minUltimate Elongation:400% min | Before agingTensile Strength:14 MPa minUltimate Elongation:500% minAfter agingTensile Strength14 MPa minUltimate Elongation:400% min | Same |
| Watertight test(1000 ml) | ASTM D5151-19 | Pass AQL 1.5 | Pass AQL 1.5 | Similar |
| Powder Residue | ASTM D6124-06(Reapproved 2017) | ≤ 2.0 mg/glove | ≤ 2.0 mg/glove | Similar |
| Biocompatibility | Primary SkinIrritation -ISO 10993-10 ThirdEdition 2010-08-01 | Under the conditionsof the study, not anirritant | Under the conditionsof the study, not anirritant | Same |
| DermalSensitization -ISO 10993-10 ThirdEdition 2010-08-01 | Under the conditionsof the study, not asensitizer | Under the conditionsof the study, not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5:2009(E) | Under the conditionsof the study, noncytotoxic | Under the conditions of thestudy cytotoxic forundiluted (neat) and 1:2dilutions but noncytotoxicfor 1:4, 1:8 and 1:16dilutions. Moreover, underthe conditions of the study,did not induce anysystemic toxicity. | Similar | |
| Acute SystemicToxicity ISO10993-11:2017(E) | Under the conditions ofstudy, the device extracts donot pose a systemic toxicity | Under the conditions of thestudy, did not induce anysystemic toxicity. | Same |
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Image /page/5/Picture/0 description: The image shows the logo for BESTSAFE. The logo consists of 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 text "BESTSAFE GLOVE CO.,LTD" in a smaller font size.
BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โกลฟ
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
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standards.
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Image /page/6/Picture/0 description: The image contains the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side and the word "BESTSAFE" in blue with a plus sign in the middle. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" also in blue.
BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โกลฟ จำกัด
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
Non-clinical testing summary 7.0
Performance Data
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine the lengthof the gloves | Min 230 mm for all sizes | Small: 243 mmMedium: 240 mmLarge: 240 mmExtra Large: 240 mm | Pass |
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine the widthof the gloves | Small: $80 \pm 10$ mmMedium: $95 \pm 10$ mmLarge: $110 \pm 10$ mmExtra Large: $120 \pm 10$ mm | Small: 85 mmMedium: 93 mmLarge: 105 mmExtra Large: 115 mm | Pass | |
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine thethickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mmMedium: Palm: 0.06 mm, Finger: 0.08 mmLarge: Palm 0.09 mm, Finger: 0.12 mmExtra Large: Palm 0.09 mm, Finger: 0.12 mm | Pass | |
| Watertight test | ASTM D5151-19Standard Test Method for Detectionof Holes in MedicalGloves | To determine the holes inthe gloves | Sample size: 200 pcsInspection level : GIAQL 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 drawn isunder code L equivalent to 200 pcs withaccept 7 and reject 8 to be accept underAQL 1.5Small: 0 (Zero)Medium: 0 (Zero)Large:0 (Zero)Extra Large:0 (Zero). | Pass |
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
| 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:1.42 mg/gloveMedium: 0.50 mg/gloveLarge: 1.34 mg/gloveExtra Large:1.36 mg/glove | Pass |
| PhysicalProperties | ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength 14MpaMinimal for all sizesAfter Ageing TensileStrength 14MpaMinimal for all sizes | Before AgeingSmall: 18.37 MPaMedium: 30.62 MPaLarge: 18.30 MPaExtra Large: 18.20 MPaAfter ageing:Small: 14.08 MPaMedium: 31.89 MPaLarge: 14.00 MPaExtra Large: 14.00 MPa | Pass |
| To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% Min for all sizesAfter Ageing UltimateElongation 400% Minfor all sizes | Before Ageing:Small: 612%Medium: 500 %Large:620%Extra Large:587%After ageing:Small:408%Medium: 499%Large:403%Extra Large:416% | Pass |
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Image /page/7/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 capital letters with a plus sign in the middle of the B. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in smaller blue capital letters. There is a registered trademark symbol in the upper right corner of the logo.
BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โกลฟ จำกัด
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
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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 the word "BESTSAFE" is the company name "BESTSAFE GLOVE CO., LTD" in blue. There is a registered trademark symbol in the upper right corner of the logo.
BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โ 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
8.0 Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion:
The conclusions drawn from the non-clinical test demonstrate that the subject device Nitrile Powder Free Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384
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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.