(274 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Non-Sterile, Powder Free Nitrile Examination Gloves – Orange, Green, Blue and Violet Color Color meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided text describes the acceptance criteria and performance data for "Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color," which is seeking substantial equivalence to a predicate device (K052502).
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Ranges for Orange, Green, Blue, Violet) |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets (Specific ranges provided below) |
| Length (Size M) | Min 230 mm (Predicate: 240-251 mm) | Orange: 242-257 mmGreen: 240-249 mmBlue: 240-250 mmViolet: 240-244 mm |
| Palm Width (Size M) | 95 ± 10 mm (Predicate: 94-96 mm) | Orange: 96-100 mmGreen: 95-99 mmBlue: 95-99 mmViolet: 96-98 mm |
| Thickness Finger (Single Layer) | Min 0.05 mm (Predicate: 0.15-0.19 mm) | Orange: 0.11-0.14 mmGreen: 0.11-0.14 mmBlue: 0.09-0.10 mmViolet: 0.09-0.11 mm |
| Thickness Palm (Single Layer) | Min 0.05 mm (Predicate: 0.12-0.16 mm) | Orange: 0.09-0.11 mmGreen: 0.07-0.08 mmBlue: 0.05-0.06 mmViolet: 0.06-0.07 mm |
| Thickness Cuff (Single Layer) | Not explicitly stated in table | Orange: 0.07-0.09 mmGreen: 0.06-0.07 mmBlue: 0.04-0.05 mmViolet: 0.05-0.06 mm |
| Physical Properties | ASTM D6319-10 | Meets (Specific ranges provided below) |
| Before Aging: Tensile Strength (MPa) | Min 14 MPa (Predicate: 26.00-30.00 MPa) | Orange: 21.21-29.63Green: 24.15-29.21Blue: 28.46-33.44Violet: 23.22-29.11 |
| Before Aging: Ultimate Elongation (%) | Min 500% (Predicate: 750-800%) | Orange: 540-600Green: 580-620Blue: 520-580Violet: 520-580 |
| After Aging: Tensile Strength (MPa) | Min 14 MPa (Predicate: 25.00-28.00 MPa) | Orange: 29.23-33.56Green: 28.72-34.84Blue: 29.76-34.18Violet: 27.39-30.82 |
| After Aging: Ultimate Elongation (%) | Min 400% (Predicate: 670-730%) | Orange: 480-520Green: 520-540Blue: 440-520Violet: 440-500 |
| Freedom from Holes (Barrier) | ASTM D6319-10 (AQL = 2.5, FDA 1000ml Water Leak Test) | Meets (Holes found: 0 for all colors; Accept 1, Reject 7 criteria) |
| AQL | AQL 2.5 (Predicate: AQL 2.5) | AQL 2.5 (Result: 0 for all colors) |
| Powder-free | ASTM D6319-10 (Max 2.0 mg/glove) | Meets (Specific values below) |
| Residual Powder | Max 2.0 mg/glove (Predicate: 0.20 mg/glove) | Orange: 0.16 mg/gloveGreen: 0.24 mg/gloveBlue: 0.20 mg/gloveViolet: 0.14 mg/glove |
| Bio-compatibility | ISO 10993-10 (2010), Non-irritant, Non-sensitizer | Meets (Under the conditions of the study, the device is non-irritant or non-sensitizer for all colors) |
Study Proving Device Meets Acceptance Criteria:
The document explicitly states that the device "meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application." The tables provided, particularly on pages 5 and 7, show the performance of the "Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color" against these ASTM D6319-10 standards, and also against the FDA 1000ml Water Leak Test and ISO 10993-10 (2010) for biocompatibility.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The specific sample sizes for each test (e.g., how many gloves were tested for length, how many for freedom from holes) are not explicitly detailed. For the "Watertight (1000ml)" test, it mentions "Multiple Normal GII AQL = 2.5", and the acceptance criterion is "(Accept 1, Reject 7)", which implies a sampling plan based on AQL principles, but not a fixed number of samples. This is a common statistical sampling approach in quality control of manufactured goods.
- Data Provenance: The manufacturer is YTY Industry (Manjung) Sdn. Bhd., located in Sitiawan, Perak, Malaysia. Therefore, the data provenance is Malaysia. The study is a prospective test of the manufactured gloves against established standards, not a retrospective analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as it's not relevant for this type of device (nitrile examination gloves). The "ground truth" for glove performance is established by objective, standardized tests (ASTM, ISO, FDA methods), not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. As mentioned above, the performance of examination gloves is determined by objective physical and chemical testing against established standards, not by human adjudication of "ground truth".
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:
- A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert human readers interpret images or data, often with or without AI assistance. This device (examination gloves) does not involve human interpretation or AI assistance in its intended use or performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone algorithm performance study was not done. This device is a physical medical product, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance of these gloves is defined by established international and national standards and test methods:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- FDA 1000ml Water Leak Test
- ISO 10993-10 (2010) (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
- ASTM D6124-10 (Reapproved 2011) (Residual Powder on Medical Gloves)
- ASTM D5151-06 (Reapproved 2011) (Detection of Holes in Medical Gloves)
8. The sample size for the training set:
- This information is not applicable. This is a physical manufactured product, not an AI/ML algorithm that requires a "training set". The manufacturing process is subject to quality control and adherence to standards.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of medical device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2015
YTY INDUSTRY (MANJUNG) SDN. BHD. Ms. Punitha Samy Assistant Manager-DC/RA Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan, Perak Malaysia
Re: K143289
Trade/Device Name: Non-Sterile, Power Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 7, 2015 Received: July 13, 2015
Dear Ms. Samy:
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. 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.
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Page 2 - Ms. Samy
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143289
Device Name
Non-Sterile Powder Free Nitrile Examintion Gloves - ORANGE, GREEN, BLUE AND VIOLET COLOR
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers 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)
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FORM FDA 3881 (8/14)
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PSC Publiching Services (301) 443-6740 FF
Sec 1 IFU Page 1 of 1
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image is a logo for YTY Industry. The logo consists of a square with a blue and white design on the left, followed by the text "YTY INDUSTRY" in blue. The word "INDUSTRY" has a blue line underneath it. The logo is simple and modern, and the blue color gives it a professional look.
510 (K) SUMMARY SHEETS
1.0 510 (K) SUMMARY 2.0 Submitter YTY INDUSTRY (MANJUNG) SDN. BHD., Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan, Perak Malaysia 605-6908533 Tel Fax 605-6908533 Name of Contact Person 1. MS. PUNITHA SAMY E-mail:punitha@ytygroup.com.my Date Summary Prepared August 11, 2015 3.0 Name of Device Trade Name: Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color. Common Name: Nitrile Examination Gloves Classification Name: Patient Examination Gloves, Powder Free Device Classification: I Regulation Number: 21 CFR 880.6250 Panel: General Hospital (80) LZA Product Code: 4.0 Identification of The Legally Marketed Devices
Predicate Device Name: Non-Sterile On Line Powder Free Nitrile Blue & White Color Examination Glove]
Predicate 510(K) number: K052502
Manufacturer's Name: YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan
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5.0 Description of The Device
Non-Sterile, Powder Free Nitrile Examination Gloves – Orange, Green, Blue and Violet Color Color meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This device is for over-the counter use.
7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Nitrile Examination Gloves -Orange, Green, Blue and Violet Color have the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristic | Standards | Performance ofNon-Sterile, Powder Free NitrileExamination Gloves - Orange,Green, Blue and Violet Color |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from holes | ASTM D6319-10 | Meets |
| Powder-free | ASTM D6319-10 | Meets |
| Bio-compatibility | Primary skin irritationISO 10993-10 (2010) | Non-Irritant |
| Dermal SensitizationISO 10993-10 (2010) | Non-sensitizer |
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| Test | FDA1000mlWater LeakTest | YTY Powder Free Nitrile Examination Gloves | Non-Sterile OnLine PowderFree NitrileBlue & WhiteColorExaminationGlovePredicateK052502 | |||
|---|---|---|---|---|---|---|
| 1. Watertight (1000ml)ASTM D5151-06 (2011)TestASTM D6319-10 | MultipleNormalGIIAQL = 2.5ASTMD6319-10 | OrangeHolesfound: 0(Accept 1,Reject 7) | GreenHolesfound: 0(Accept 1,Reject 7) | BlueHoles found:0(Accept 1,Reject 7) | VioletHolesfound: 0(Accept 1,Reject 7) | Holes found: 0(Accept 1,Reject 7) |
| 2. Length (mm)Size M | Min 230 | 242-257 | 240-249 | 240-250 | 240-244 | 240-251 |
| 3. Palm width (mm)Size M | 95 ± 10 | 96-100 | 95-99 | 95-99 | 96-98 | 94-96 |
| 4. Thickness (mm)(Single Layer) | ||||||
| FingerPalm | Min 0.05Min 0.05 | 0.11-0.140.09-0.11 | 0.11-0.140.07-0.08 | 0.09-0.100.05-0.06 | 0.09-0.110.06-0.07 | 0.15-0.190.12-0.16 |
| 5. Physical Properties | ||||||
| Before AgingTensile Strength (MPa)Ultimate Elongation(%) | Min 14Min 500 | 21.21-29.63540-600 | 24.15-29.21580-620 | 28.46-33.44520-580 | 23.22-29.11520-580 | 26.00-30.00750-800 |
| After AgingTensile Strength (MPa) | Min 14 | 29.23-33.56 | 28.72-34.84 | 29.76-34.18 | 27.39-30.82 | 25.00-28.00 |
| Ultimate Elongation(%) | Min 400 | 480-520 | 520-540 | 440-520 | 440-500 | 670-730 |
| 6. Residual PowderASTM-D6124-10(Reapproved 2011) | Max2.0mg/glove | 0.16mg/glove | 0.24mg/glove | 0.20mg/glove | 0.14mg/glove | 0.20mg/ glove |
| 7. BiocompatibilityPrimary Skin IrritationDermal Sensitization | ISO 10993-10 (2010)Non-irritantNon-sensitizer | Under theconditionsof thestudy, thedevice isnon-irritantor non-sensitizer | Under theconditionsof thestudy, thedevice isnon-irritantor non-sensitizer | Under theconditions ofthe study,the device isnon-irritantor non-sensitizer | Under theconditionsof thestudy, thedevice isnon-irritantor non-sensitizer | Non-irritantNon-sensitizer |
Sec 1 Sum Page 3 of 6
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| Characteristics | Applicant | Predicate K052502 | Medical GloveManual (1661) | |||
|---|---|---|---|---|---|---|
| Blue -Grape | Blue -Apple | Blue -Peppermint | Blue -Vanilla | |||
| Company Name | YTY Industry (Manjung) Sdn Bhd | YTY Industry (Manjung)Sdn Bhd | FDA | |||
| Product Name | Non-Sterile, Powder Free Scented BlueNitrile Examination Gloves | Non-Sterile, On LinePowder Free NitrileBlue & White ColorExamination Gloves | Patient ExaminationGloves | |||
| Product Code | LZA | LZA | LZA – (Polymer –other than Vinyl(includes Nitrile,Polyurethane, etc.) | |||
| Indication for Use | A patient examination gloves is a disposabledevice intended for medical purpose that is wornon the examiner's hand or fingers to preventcontamination between patient and examiner. | This is a medical gloveto be worn on the handof health care andsimilar personnel toprevent contaminationbetween health carepersonnel and thepatient. | Powder-FreeExamination GlovesA powder-free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner. | |||
| Device Description | Non-Sterile, Powder Free Scented BlueNitrile Examination Gloves meets all thecurrent specifications listed under the ASTMSpecification D6319-10, Standard Specificationfor Nitrile Examination Gloves for MedicalApplication. This device is for over-the countersingle use. | Class 1 Nitrile PatientExamination Glove80LZA, powder free thatmeets all requirements ofASTM Standard D6319-00ae3 and FDA waterleak test. | This gloves meet allcurrent specificationslisted under ASTMspecifications D6319-10 | |||
| Over the CounterUse | This device is for over-the counter single use. | This device is for over-the counter single use. | Indication for use | |||
| Single Use | Single Use | Single Use | Labeling | |||
| Non Sterile orSterile | Non Sterile | Non Sterile | Sterilization | |||
| Powder Free | Powder Free | Powder Free | Process & Attributelabeling | |||
| Compare materials | ||||||
| Materials | Carboxylated Butadiene Acrylonitrile | Carboxylated ButadieneAcrylonitrile | LZA - (Polymer -other than Vinyl(includes Nitrile,Polyurethane, etc.) |
8.0 Substantial Equivalence Comparison Table with Predicate Device, K052502
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| Characteristics | K143289 | Predicate K052502 | Medical Glove | |||
|---|---|---|---|---|---|---|
| Orange | Geen | BlueYTY Industry (Manjung) Sdn Bhd | YTY Industry | Manual (1661) | ||
| Company Name | ||||||
| Specifications and | Dimension: Finger & Palm Thickness min: 0.05mm | Current gloves | ||||
| Performance | Physical Properties: Min 14MPa Before and After Aging | meet ASTM | ||||
| Barrier: AQL 2.5 | D6319-10 Nitrile | |||||
| Tensile Strength | 21.21- | 24.15- | 28.46- | 23.22- | 26.00-30.00 | gloves |
| before aging (MPa) | 29.63 | 29.21 | 33.44 | 29.11 | ||
| Tensile Strength after | 29.23- | 28.72- | 29.76- | 27.39- | 25.00-28.00 | ASTM D6124-06 |
| aging (MPa) | 33.56 | 34.84 | 34.18 | 30.82 | (Reapproved | |
| Ultimate Elongation | 540-600 | 580-620 | 520-580 | 520-580 | 750-800 | 2011) |
| before aging (%) | Residual Powder | |||||
| Ultimate Elongation | 480-520 | 520-540 | 440-520 | 440-500 | 670-730 | |
| after aging (%) | ASTM D5151-06 | |||||
| Dimensions Length | 242-257 | 240-249 | 240-250 | 240-244 | 240-251 | (Reapproved |
| (mm) | 2011) Detection | |||||
| Dimensions Width | 96-100 | तेर-तेते | तेर-तेत्र | 96-98 | 94-96 | of Holes in |
| (mm) | Medical Gloves | |||||
| Thickness Finger | 0.11-0.14 | 0.11-0.14 | 0.09-0.10 | 0.09-0.11 | 0.15-0.19 | |
| (mm) | ||||||
| Thickness Cuff (mm) | 0.07-0.09 | 0.06-0.07 | 0.04-0.05 | 0.05-0.06 | 0.09-0.10 | |
| Thickness Palm | 0.09-0.11 | 0.07-0.08 | 0.05-0.06 | 0.06-0.07 | 0.12-0.16 | |
| (mm) | ||||||
| AQL | AQL 2.5 | AQL 2.5 | AQL 2.5 | AQL 2.5 | AQL 2.5 | |
| Result: 0 | Result: 0 | Result: 0 | Result: 0 | Result: 0 | ||
| Residual Powder | 0.16mg/ | 0.24mg/ | 0.20mg/ | 0.14mg/ | 0.20mg/glove | |
| (mg/glove) | glove | glove | glove | glove | ||
| Size | M | M | M | M | M | |
| Bio-compatibility | Under the | Under the | Under the | Under the | Non-irritant | ISO 10993-10 |
| condition | condition | condition | condition | Non-sensitizer | Test for Irritation | |
| of the | of the | of the | of the study | and Skin | ||
| study the | study the | study the | the device | Sensitization | ||
| device is | device is | device is | is non- | |||
| non- | non- | non- | irritant and | |||
| irritant | irritant | irritant | non- | |||
| and non- | and non- | and non- | sensitizer | |||
| sensitizer | sensitizer | sensitizer | ||||
| Labeling for legally | -Powder Free | -Powder Free | Chapter 4 - | |||
| marketed predicate | -devices color | -devices color: | Labeling | |||
| -Scent | Clear (Blue) | |||||
| -Patient Examination Glove | -Patient | |||||
| -Non sterile | Examination Glove | |||||
| -Single Use Only | -Non sterile | |||||
| -Manufactured for | -Single Use Only-Manufactured for: | |||||
| -Lot-Intended use | -Lot | |||||
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9.0 Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the device, Non-Sterile, Powder Free Nitrile Examination Gloves – Orange, Green, Blue and Violet Color and the predicate device is substantially equivalent based on intended uses, physical properties, technological characteristics and non-clinical performance. This device is as safe, effective, and performs as well as the predicate device.
§ 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.