(307 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.
This document describes the acceptance criteria and performance data for Mexpo International Inc.'s Non Sterile Nitrile Powder Free Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria are based on the ASTM D6319 and ASTM D6124 standards for nitrile examination gloves.
| Characteristic | ASTM D6319/D6124 Requirement | Reported Device Performance (Table 3, for Blue, Green, and Black Gloves) |
|---|---|---|
| DIMENSIONS | ||
| Overall Length | Small: Pass (237-253 mm) Medium: Pass (240-251 mm) Large: Pass (240-255 mm) X-Large: Pass (241-277 mm) | |
| - Small | 220 mm minimum | Pass |
| - Medium | 230 mm minimum | Pass |
| - Large | 230 mm minimum | Pass |
| - X-large | 230 mm minimum | Pass |
| Width | Small: Pass (85-88 mm) Medium: Pass (95-98 mm) Large: Pass (105-109 mm) X-Large: Pass (113-116 mm) | |
| - Small | $80 \pm 10$ mm | Pass |
| - Medium | $95 \pm 10$ mm | Pass |
| - Large | $110 \pm 10$ mm | Pass |
| - X-large | $120 \pm 10$ mm | Pass |
| Palm Thickness | 0.05 mm minimum | Small: Pass (0.06-0.14 mm) Medium: Pass (0.06-0.13 mm) Large: Pass (0.05-0.13 mm) X-Large: Pass (0.06-0.13 mm) |
| Finger Thickness | 0.05 mm minimum | Small: Pass (0.09-0.17 mm) Medium: Pass (0.09-0.18 mm) Large: Pass (0.10-0.16 mm) X-Large: Pass (0.10-0.16 mm) |
| PHYSICAL PROPERTIES | ||
| Tensile Strength (Before Aging) | 14 MPa minimum | Small: Pass (24.1-41.2 MPa) Medium: Pass (25.9-46.5 MPa) Large: Pass (21.2-42.2 MPa) X-Large: Pass (19.6-43.5 MPa) |
| Tensile Strength (After Aging) | 14 MPa minimum | Small: Pass (24.4-43.5 MPa) Medium: Pass (24.8-45.8 MPa) Large: Pass (20.7-43.0 MPa) X-Large: Pass (21.6-44.8 MPa) |
| Ultimate Elongation (Before Aging) | 500% minimum | Small: Pass (500-600%) Medium: Pass (500-600%) Large: Pass (500-600%) X-Large: Pass (460-560%) Note: X-Large Black glove reports 460-540%, which includes values below 500% (e.g., 460%). This is a slight discrepancy against the "500% minimum" requirement, though generally reported as "Pass". |
| Ultimate Elongation (After Aging) | 400% minimum | Small: Pass (460-580%) Medium: Pass (460-600%) Large: Pass (480-560%) X-Large: Pass (440-560%) |
| FREEDOM FROM HOLES (Pinhole Inspection) | AQL=2.5 | Small: Pass (Found=0-2) Medium: Pass (Found=0) Large: Pass (Found=0-1) X-Large: Pass (Found=1-6) |
| Inspection Level | G-1 | Pass |
| POWDER FREE/Powder Content | Does not exceed 2 mg/glove | Small: Pass (Average: 0.04-0.36 mg/glove) Medium: Pass (Average: 0.06-0.70 mg/glove) Large: Pass (Average: 0.04-0.30 mg/glove) X-Large: Pass (Average: 0.10-1.02 mg/glove) |
| BIOCOMPATIBILITY | ISO 10993-10, ISO 10993-11 | Non-irritant, non-sensitizer, no acute systemic toxic effects. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the total sample size across all tests for the subject device. However, for the "Freedom from Holes (Pinhole Inspection)" test, the sample size per size/color variation is reported as n=200 gloves (as indicated by "Accept on 10 (n=200)" or "Accept on 7 (n=200)"). The specific number of gloves tested for other physical and dimensional properties is not detailed, but it is implied that sufficient samples were tested to demonstrate compliance with ASTM standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It presents the results as "Summary of Device Specifications and Performance Results" and "Performance Test Results Comparison," implying the data was generated from testing of the subject gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this type of device (nitrile examination gloves). The "ground truth" for glove performance is established by objective, standardized laboratory tests according to recognized industry standards (ASTM D6319, ASTM D6124, ISO 10993 series for biocompatibility), not by expert consensus in the way medical imaging or diagnostic devices might require.
4. Adjudication Method for the Test Set:
This information is not applicable. As standard laboratory tests are used, there is no subjective interpretation requiring an adjudication method. The results are quantitative measurements or pass/fail criteria against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device on human expert performance, which is not relevant for examination gloves.
6. If a Standalone Performance Study Was Done:
Yes, a standalone (algorithm only, without human-in-the-loop performance) study was done. The document presents the performance of the device itself against recognized objective standards without requiring human interaction or interpretation beyond performing the tests. The results in Table 3 directly reflect the intrinsic properties of the gloves.
7. The Type of Ground Truth Used:
The ground truth used is based on established industry standards and objective physical/chemical measurements. Specifically:
- ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-06 (2011): Standard Test Method for Detection of Holes in Medical Gloves
- ISO 10993-10: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11: Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
These standards define the acceptable ranges and methodologies for determining the "truth" of a glove's dimensions, physical properties, freedom from holes, and biocompatibility.
8. The Sample Size for the Training Set:
This information is not applicable. Examination gloves do not typically involve a "training set" in the context of machine learning or AI. The manufacturing process is controlled to consistently produce gloves meeting specifications.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8. The "ground truth" for quality control and manufacturing is the continuous adherence to the established product specifications and the ASTM/ISO standards.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 13, 2021
Mexpo International Inc. Tim Thai Official Correspondent 2828 Faber Street Union City, California 94587
Re: K210388
Trade/Device Name: Non Sterile Nitrile Powder Free Examination Gloves - Blue, Green and Black color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 10, 2021 Received: November 12, 2021
Dear Tim Thai:
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 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).
Sincerely,
For Clarence W. Murray III, PhD 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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Indications for Use
510(k) Number (if known) K210388
Device Name
NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES - BLUE, GREEN AND BLACK COLOR
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is wom 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)
11
|X] Over-The-Counter Use (21 CFR 801 Subpart C)
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510K SUMMARY
Date of Summary Prepared: November 9, 2021
510K Number: K210388
- Applicant : MEXPO INTERNATIONAL INC. Address : 2828 Faber Street, Union City, CA 94587, U.S.A. Tel : 510 — 489 6800 Fax : 510-489 3111 E-mails : : mexpoglove@aol.com and acct@mexpo-glove.com
Official Correspondence: Tim Thai (President)
-
- Device Name: Non Sterile Nitrile Powder Free Examination Gloves Blue, Green And Black color.
3. Regulatory Information
| Classification Name | : Nitrile Powder Free Examination Gloves |
|---|---|
| Classification | : Class I |
| Product Code | : LZA |
| Regulation Number | : 21 CFR 880.6250 |
4. Predicate Device
| 510K Number | : K143289- YTY Industry (Manjung) Sdn. Bhd. |
|---|---|
| Device Name | : Non Sterile, Powder Free Nitrile Examination Gloves -Orange, Green, Blue and Violet Color. |
5. Intended 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.
6. Description
The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.
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| Summary of Comparison and Technological Characteristic | ||||
|---|---|---|---|---|
| Table 1 - General Comparison | ||||
| SUBJECT DEVICE:K210388 | PREDICATE DEVICE:K143289 | Comparison | ||
| Company Name | Mexpo International Inc. | YTY INDUSTRY(MANJUNG) SDN. BHD | ||
| Product Name | Non Sterile, Powder FreeNitrile ExaminationGloves-BLUE, GREEN ANDBLACK | Non Sterile, Powder FreeNitrile ExaminationGloves-Orange, Green,Blue and Violet Color | ||
| Available Colors | Blue, Green and Black | Blue, Green and Others | Similar | |
| Available Sizes | Small, Medium, Large andX-Large | Not specified but dataprovided on Medium | Similar | |
| Indications for Use | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. | A patient examinationgloves is a disposabledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | Similar. The subjectdevice includes languageto clarify that it ispowder free asrecommended in theFDA's Glove GuidanceDocument | |
| MATERIALS | Carboxylated ButadieneAcrylonitrile as basematerial | Carboxylated ButadieneAcrylonitrile as basematerial | Same | |
| DIMENSIONS | Meets ASTM D6319Criteria | Meets ASTM D6319Criteria | Same | |
| PHYSICALPROPERTIES | Meets ASTM D6319Criteria | Meets ASTM D6319Criteria | Same | |
| FREEDOM FROMHOLES/Watertight | Meets ASTMD6319/ASTM D5151Criteria | Meets ASTM D5151Criteria | Same | |
| POWDERFREE/Residual Powder | Meets ASTM D6124Criteria | Meets ASTM D6124Criteria | Same | |
| BIOCOMPATABILITY | Per ISO 10993-10: Non-irritant (ResponseCategory is Negligible)and Non-sensitizer (Nosensitization)Per ISO 10993-11: AcuteSystemic Toxicity; Notoxic effects | Per ISO 10993-10: Non-irritant andNon-sensitizer | Same | |
| Product CommonName | Non sterile Nitrile PowderFree Examination Gloves | Non sterile Nitrile PowderFree Examination Gloves | Same | |
| Product Code/Class | LZAClass I(21 CFR 880.6250) | LZAClass I(21 CFR 880.6250) | Same | |
| Sterility/Use | Non-Sterile/Single Use | Non-Sterile/Single Use | Same | |
| OTC Use | Yes | Yes | Same | |
| SUBJECT DEVICE:K210388 | PREDICATE DEVICE:K143289 | Comparison | ||
| MexpoInternational Inc | YTY INDUSTRY(MANJUNG) SDN.BHD | |||
| Glove Color/Size | BLUE/Medium | BLUE/Medium | ||
| DIMENSION | ASTM D6319Accept Criteria | |||
| Overall Length | 230 mmMinimum | 240-246 mm | 240-250 mm | Same. Both meetASTM D6319Acceptance Criteria |
| Width | 95 +/-10 mm | 95-98 mm | 95-99 mm | Same. Both meetASTM D6319Acceptance Criteria |
| Palm Thickness | 0.05 mmMinimum | 0.06-0.06 mm | 0.05-0.06 mm | Same. Both meetASTM D6319Acceptance Criteria |
| Finger thickness | 0.05 mmMinimum | 0.09-0.10 mm | 0.09-0.10 mm | Same. Both meetASTM D6319Acceptance Criteria |
| PHYSICAL PROPERTIES | ||||
| Tensile Strength(before aging) | 14 MPa,Minimum | 25.9-32.0 MPa | 28.46-33.44 MPa | Same. Both meetASTM D6319Acceptance Criteria |
| Tensile Strength(after aging) | 14 MPa,Minimum | 25.4-34.0 MPa | 29.76-34.18 MPa | Same. Both meetASTM D6319Acceptance Criteria |
| Ultimate Elongation(before aging) | 500 %Minimum | 500-540 % | 520-580 % | Same. Both meetASTM D6319Acceptance Criteria |
| Ultimate Elongation(after aging) | 400 %Minimum | 480-520 % | 440-520 % | Same. Both meetASTM D6319Acceptance Criteria |
| FREEDOM FROMHOLES/Watertight | Per ASTMD5151-06(2011) | Holes Found: 0 | Holes Found: 0(Accept 1, Reject 7) | Same. Both meetASTM D6319Acceptance Criteria |
| Pinhole AQL | InspectionLevel G-1;AQL=2.5 | Inspection Level G-1; AQL=2.5 | Inspection Level G-1; AQL=2.5 | Same. Both meetASTM D6319Acceptance Criteria |
| POWDERFREE/ResidualPowder | Residue limitof 2.0mg/glove | 0.70 mg/glove | 0.20 mg/glove | Same. Both meetASTM D6124Acceptance Criteria |
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Table 2 Specifications and Performance Test Results Comparison
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Table 3 Summary of Device Specifications and Performance Results
| ASTM D6319Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | |
|---|---|---|---|---|
| DIMENSIONS | ||||
| Overall Length | ||||
| -Small | 220 mm minimum | Pass (242-253 mm) | Pass (237-243 mm) | Pass (239-248 mm) |
| -Medium | 230 mm minimum | Pass (240-246 mm) | Pass (240-247 mm) | Pass (244-251 mm) |
| -Large | 230 mm minimum | Pass (245-255 mm) | Pass (240-247 mm) | Pass (243-251 mm) |
| -X large | 230 mm minimum | Pass (243-253 mm) | Pass (240-250 mm) | Pass (241-277 mm) |
| Width | ||||
| -Small | $80 \pm 10$ mm | Pass (85-87 mm) | Pass (86-88 mm) | Pass (85-86 mm) |
| -Medium | $95 \pm 10$ mm | Pass (95-98 mm) | Pass (95-96 mm) | Pass (95-97 mm) |
| -Large | $110 \pm 10$ mm | Pass (106-109 mm) | Pass (106-106 mm) | Pass (105-106 mm) |
| -X large | $120 \pm 10$ mm | Pass (113-115 mm) | Pass (114-116 mm) | Pass (115-115 mm) |
| Palm Thickness | ||||
| -Small | 0.05 mmminimum | Pass (0.06-0.07 mm) | Pass (0.12-0.14 mm) | Pass (0.07-0.08 mm) |
| -Medium | 0.05 mmminimum | Pass (0.06-0.06 mm) | Pass (0.13-0.13 mm) | Pass (0.07-0.07 mm) |
| -Large | 0.05 mmminimum | Pass (0.05-0.07 mm) | Pass (0.11-0.13 mm) | Pass (0.07-0.07 mm) |
| -X large | 0.05 mmminimum | Pass (0.06-0.06 mm) | Pass (0.12-0.13 mm) | Pass (0.06-0.07 mm) |
| Finger thickness | ||||
| -Small | 0.05 mmminimum | Pass (0.09-0.11 mm) | Pass (0.15-0.17 mm) | Pass (0.11-0.13 mm) |
| -Medium | 0.05 mmminimum | Pass (0.09-0.10 mm) | Pass (0.15-0.18 mm) | Pass (0.11-0.13 mm) |
| -Large | 0.05 mmminimum | Pass (0.10-0.11 mm) | Pass (0.15-0.16 mm) | Pass (0.11-0.13 mm) |
| -X large | 0.05 mmminimum | Pass (0.10-0.11 mm) | Pass (0.15-0.16 mm) | Pass (0.11-0.14 mm) |
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| ASTM D6319Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | |
|---|---|---|---|---|
| PHYSICAL PROPERTIES | ||||
| Tensile Strength (Before Aging) | ||||
| -Small | 14 MPa minimum | Pass (25.2-31.9 MPa) | Pass (24.1-34.1 MPa) | Pass (33.5-41.2 MPa) |
| -Medium | 14 MPa minimum | Pass (25.9-32.0 MPa) | Pass (25.9-32.0 MPa) | Pass (34.3-46.5 MPa) |
| -Large | 14 MPa minimum | Pass (23.9-34.3 MPa) | Pass (21.2-28.8 MPa) | Pass (31.6-42.2 MPa) |
| -X large | 14 MPa minimum | Pass (28.2-39.2 MPa) | Pass (19.6-29.9 MPa) | Pass (25.2-43.5 MPa) |
| Tensile Strength (After Aging) | ||||
| -Small | 14 MPa minimum | Pass (25.6-34.9 MPa) | Pass (24.4-38.1 MPa) | Pass (25.7-43.5 MPa) |
| -Medium | 14 MPa minimum | Pass (25.4-34.0 MPa) | Pass (24.8-32.3 MPa) | Pass (34.7-45.8 MPa) |
| -Large | 14 MPa minimum | Pass (24.0-37.4 MPa) | Pass (20.7-33.9 MPa) | Pass (35.1-43.0 MPa) |
| -X large | 14 MPa minimum | Pass (33.2-40.2 MPa) | Pass (21.6-32.1 MPa) | Pass (24.7-44.8 MPa) |
| Ultimate Elongation (Before Aging) | ||||
| -Small | 500% minimum | Pass (500-540%) | Pass (500-580%) | Pass (540-600%) |
| -Medium | 500% minimum | Pass (500-540%) | Pass (500-560%) | Pass (520-600%) |
| -Large | 500% minimum | Pass (500-560%) | Pass (500-580%) | Pass (520-600%) |
| -X large | 500% minimum | Pass (500-560%) | Pass (540-580%) | Pass (460-540%) |
| Ultimate Elongation (After Aging) | ||||
| -Small | 400% minimum | Pass (480-520%) | Pass (460-540%) | Pass (540-580%) |
| -Medium | 400% minimum | Pass (480-520%) | Pass (460-540%) | Pass (520-600%) |
| -Large | 400% minimum | Pass (480-520%) | Pass (480-560%) | Pass (520-560%) |
| -X large | 400% minimum | Pass (480-520%) | Pass (500-560%) | Pass (440-520%) |
| ASTM D6319 Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | |
|---|---|---|---|---|
| FREEDOM FROM HOLES (Pinhole Inspection) | ||||
| -Small | AQL=2.5; Accept on 10 (n=200) | Pass (Found=1) | Pass (Found=0) | Pass (Found=2) |
| -Medium | AQL=2.5; Accept on 7 (n=200) | Pass (Found=0) | Pass (Found=0) | Pass (Found=0) |
| -Large | AQL=2.5; Accept on 10 (n=200) | Pass (Found=1) | Pass (Found=1) | Pass (Found=0) |
| -X Large | AQL=2.5; Accept on 10 (n=200) | Pass (Found=0) | Pass (Found=6) | Pass (Found=1) |
| ASTM D6124Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | |
| POWDER FREE/Powder Content | ||||
| -Small | does not exceed 2mg per glove | Pass (Average: 0.36mg per glove) | Pass (Average: 0.18mg per glove) | Pass (Average: 0.04mg per glove) |
| -Medium | Does not exceed2 mg per glove | Pass (Average: 0.70mg per glove) | Pass (Average: 0.10mg per glove) | Pass (Average: 0.06mg per glove) |
| -Large | Does not exceed2 mg per glove | Pass (Average: 0.30mg per glove) | Pass (Average: 0.16mg per glove) | Pass (Average: 0.04mg per glove) |
| -X Large | Does not exceed2 mg per glove | Pass (Average: 1.02mg per glove) | Pass (Average: 0.24mg per glove) | Pass (Average: 0.10mg per glove) |
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7. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210388, MEXPO NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES – BLUE, GREEN AND BLACK, is as safe, as effective, and performs as well as or better than the legally marketed predicate device Non Sterile, Powder Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color in K143289.
§ 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.