(98 days)
SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
SHARK GLOVES and INCONGLOVE 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
This document describes the acceptance criteria and study results for SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the length of the gloves | Min 230 mm for all sizes | Small: Pass, Medium: Pass, Large: Pass, X-Large: Pass |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the width of the gloves | Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | Small: Pass, Medium: Pass, Large: Pass, X-Large: Pass |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | All sizes: Palm Pass, Finger Pass |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Physical properties - Tensile Strength) | To Determine the physical properties Tensile strength | Before Ageing: Tensile Strength 14Mpa Min for all sizes. After Ageing: Tensile Strength 14Mpa Min for all sizes. | All sizes: Pass (Both before and after ageing) |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Physical properties - Ultimate Elongation) | To Determine the physical properties Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizes. After Ageing: Ultimate Elongation 400% Min for all sizes. | Small, Medium, Large, X-Large: Pass (Both before and after ageing) |
| ASTM D5151-19 Standard Test Method for detection of holes in medical gloves | To determine the holes in the gloves | AQL 2.5 | Pass |
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Small, Medium, Large, X-Large: Residual Powder Content Pass |
| ISO 10993-10:2010 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done for irritation. | To determine the potential of the material to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO10993-10:2010 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done Skin sensitization. | To determine the skin sensitization potential of the material in Guinea Pig. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity. | To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts cells using elution method. | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. |
| ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity. | To determine the acute systemic toxicity potential of the test item extracts in Swiss Albino mice. | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test listed (e.g., number of gloves tested for length, width, etc.). However, the tests are conducted in accordance with ASTM and ISO standards, which typically specify sampling plans.
The data provenance is from non-clinical tests conducted for the SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free. The manufacturer and exporter is SRIRUNGRUANG GLOBAL CO., LTD, located in Thailand. The studies are prospective as they were conducted specifically for this 510(k) submission to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts or the establishment of ground truth in the context of clinical or diagnostic studies. The tests described are non-clinical, laboratory-based physical and biocompatibility assessments of the gloves. Therefore, the concept of "ground truth" established by experts, as it would be for diagnostic accuracy studies, is not applicable here. 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. As noted above, these are non-clinical laboratory tests with objective pass/fail criteria based on established standards, not studies requiring expert adjudication of results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, nor is it a study involving human readers or cases. It is a submission for patient examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on the specified quantitative and qualitative requirements of the referenced ASTM and ISO standards, such as minimum length, tensile strength, maximum powder residue, and the absence of irritation or sensitization. For the biocompatibility tests that showed cytotoxicity but no systemic toxicity concern, the "ground truth" was established through additional testing to confirm the lack of systemic risk.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (examination gloves), not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 29, 2021
Srirungruang Global Co., LTD. % Aristotle Nafpliotis Regulatory Affairs Consultant/Engineer mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K212308
Trade/Device Name: SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 27, 2021 Received: September 28, 2021
Dear Aristotle Nafpliotis:
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.
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542 of the Act); 21 CFR 1000-1050.
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 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-
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.
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)
K212308
Device Name
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free INCONGLOVE Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a stylized shark fin above the word "SHARK" in a smaller font, stacked above the word "GLOVES" in a larger font. The text and shark fin are outlined in black, with the interior of the fin filled in with a dark blue color.
510(k) SUMMARY
The assigned 510(k) number is: K212308.
1. Submitter's Identification:
- SRIRUNGRUANG GLOBAL CO., LTD Name:
51/7 MOO 1, MABPHAI, BANBUNG, CHONBURI 20170 THAILAND Address:
Phone no.: +66(0)38 151671
+66(0)38 151672 Fax no:
| Contact person: | Mr.Suttichai Sripradub |
|---|---|
| ----------------- | ------------------------ |
Designation: Managing Director
Manufacturer:
| Name: | SRIRUNGRUANG GLOBAL CO., LTD |
|---|---|
| Address: | 51/7 MOO 1, MABPHAI, BANBUNG, CHONBURI 20170 THAILAND |
| Phone no.: | +66(0)38 151671 |
| Fax no: | +66(0)38 151672 |
Exporter: SRIRUNGRUANG GLOBAL CO., LTD.
Date Summary Prepared: May 31, 2021
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Image /page/4/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized shark fin in blue, with a white outline. Below the shark fin, the words "SHARK" and "GLOVES" are stacked on top of each other in a bold, sans-serif font, also in blue with a white outline. The overall design is clean and sporty.
2. Device Identification
| Name of the Device: | SHARK GLOVES Blue Nitrile Examination GlovePowder FreeINCONGLOVE Blue Nitrile Examination GlovesPowder free |
|---|---|
| Trade Name (s): | SHARK GLOVES, INCONGLOVE |
| Common or usual name: | Exam Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered patient examination gloves. |
| Regulatory Class: | I |
| Product Code: | LZA |
| Review Panel: | General Hospital |
Information for the 510(k) Cleared Device (Predicate Device): 3.
| Predicate Device: | JR MEDIC Blue Nitrile Examination Gloves PowderFree |
|---|---|
| Owner: | JR Engineering & Medical Technologies (M) SDN.BHD. |
| 510(k) Number: | K192333 |
| Regulatory Class: | I |
| Product Code: | LZA |
4. Device Description:
SHARK GLOVES and INCONGLOVE 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
ട്. Indications for Use:
SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner
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Image /page/5/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized shark fin in blue, with a white outline, positioned above the text "SHARK" and "GLOVES", which are stacked on top of each other. The text is in a bold, sans-serif font, with a white outline and a black shadow, giving it a three-dimensional effect. The overall design is sporty and eye-catching.
6. Technological Characteristic Comparison of Proposed and Predicate Devices:
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |
|---|---|---|---|---|
| PREDICATE | SUBJECT | |||
| 510(k) Number | K192333 | K212308 | ------ | |
| Name of device | Blue NitrileExamination GlovesPowder Free | SHARK GLOVES andINCONGLOVE | ------ | |
| Dimensions | ASTMD6319-10(Reapproved 2015)ASTMD6319-19 | Length Min 230 mmWidth Min 95+/-10mm(for medium size) | Length Min 230 mmWidth Min 95+/-10mm(for medium size) | Same |
| Physical Properties | ASTMD6319-10(Reapproved 2015)ASTMD6319-19 | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Before AgingTensile Strengthmin 14 MpaUltimate Elongation Min500%After AgingTensile Strengthmin 14 MpaUltimate Elongation Min400% | Similar |
| Thickness | ASTMD6319-10(Reapproved 2015)ASTMD6319-19 | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same |
| Powder Free, Powderresidue | ASTMD6319-10ASTMD6319-19 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary SkinIrritation-ISO 1993-10:2010(E) | Under the condition ofstudy not an irritant | Under the condition ofstudy not an irritant | Same |
| Dermal Sensitization-ISO 10993-10:2010(E) | Under the conditionsof the study not asensitizer | Under the conditions ofthe study not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5 :2009(E) | Under the conditionsof the study,cytotoxic.Additional testing wasperformed todetermine if this wasa systemic toxicityconcern | Under the conditions ofthe study, cytotoxic.Additional testing wasperformed to determineif this was a systemictoxicityconcern | Similar | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditionof study the deviceextracts do not pose asystemic toxicityconcern | Under the conditionof study the deviceextracts do not pose asystemic toxicityconcern | Similar | |
| Material MediatedPyrogenicity ISO10993-11:2017(E) /USP 41<151> | Under the conditionsof the study, thedevice did notdemonstrate amaterial mediatedpyrogenicity response. | Under the conditions ofthe study, the devicedid not demonstrate amaterial mediatedpyrogenicity response. | Similar | |
| Water Tight (1000 ml),Freedom from holes | ASTM D5151-06ASTM D5151-19 | Passes AQL-2.5 | Passes | Similar |
| Indications for Use | JR MEDIC BlueNitrile ExaminationGloves Powder Freeis disposable deviceintended for medicalpurpose that are wonon the examiner'shand to preventcontaminationbetween patient andexaminer. | SHARK GLOVES andINCONGLOVE BlueNitrile ExaminationGloves Powder Free aredisposable devicesintended for medicalpurpose that are won onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Similar | |
| Material | ASTMD6319-10(ReapprovedASTMD6319-19 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTMD6319-10(Reapproved 2015)ASTMD6319-19 | Extra Small, Small,Medium, Large, ExtraLarge | Small, Medium, Large,Extra Large | Similar |
| Single Use | Medical GloveGuidance Manual -Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | - | JR Engineering &Medical Technologies(M) SDN.BHD.Malaysia. | SRIRUNGRUANGGLOBAL CO., LTD.51/7 ΜΟΟ 1,MABPHAI, BANBUNG,CHONBURI20170 THAILAND |
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Image /page/6/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK" and "GLOVES" are stacked on top of each other in a bold, sans-serif font, also in blue with a white outline. The overall design is sporty and suggests a brand associated with athletic or protective gloves.
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Image /page/7/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a blue shark with a white outline above the word "GLOVES" in large, bold, red letters. The word "SHARK" is in smaller, black letters above the word "GLOVES".
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.
7. Summarv of Non-Clinical Testing:
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Image /page/8/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK" and "GLOVES" are stacked on top of each other in a stylized font. The word "SHARK" is slightly smaller and positioned above the word "GLOVES".
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application | To determine thelength of the gloves | Min 230 mm for all sizes | Small: PassMedium: PassLarge: PassX-Large: Pass |
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application | To determine thewidth of the gloves | Small: -80+/-10 mmMedium: -95+/-10mmLarge: -110+/-10 mmX-Large: -120+/-10 mm | Small: PassMedium: PassLarge: PassX-Large: Pass |
| Test Method | Purpose | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application | To determinethe length of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | SizeSmallMediumLargeX-large | PalmPass | FingerPass |
| ASTM D6319-19Standard Specificationphysical properties- forNitrile Examination GlovesUltimate Elongation forMedical Application | To Determinethe physicalproperties Tensilestrength | Before AgeingTensile Strength14Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for all size | SizeSmallMediumLargeX-large | Pass | Pass |
| To Determine thephysical propertiesUltimate Elongation | Before AgeingUltimate Elongation500% Min for allSize After Ageing | SizeSmallMedium | BeforeageingPass | AfterageingPass |
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Image /page/9/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK GLOVES" are written in a bold, stylized font, with "SHARK" stacked above "GLOVES". The text also has a white outline, making it stand out against the background.
| Ultimate Elongation400% Min for all sizes | LargeX-large | ||||
|---|---|---|---|---|---|
| -- | -- | ----------------------------------------------- | ------------------ | -- | -- |
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ASTM D5151-19Standard Test Method fordetection of holes inmedical gloves | To determine the holesin the gloves | AQL 2.5 | Pass |
| ASTM D6124-06Standard Test Method forResidual Powder onMedical Gloves | To determine theresidual powder in thegloves | 2 Mg/Glove Max | SizeSmallMediumLargeX-Large |
| Residual PowderContentPass |
The indications for use, materials, size and models are all similar. Both the subject and predicate devices are shown to be biocompatible and meet the specifications of the ASTM standard D6319-10.
BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ------------- | --------- | --------------------- | -------- |
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Image /page/10/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a blue shark with a white outline. The words "SHARK" and "GLOVES" are stacked on top of each other in red font below the shark. The logo has a sporty and dynamic feel.
| ISO 10993-10:2010Biological Evaluation ofMedical Devices Test forIrritation and SkinSensitization. Test done forirritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the condition ofstudy not an irritant | Under the conditionof study not an irritant |
|---|---|---|---|
| ISO10993-10:2010Biological Evaluation ofMedical Devices Test forIrritation and SkinSensitization. Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under the conditionsof the study not asensitizer | Under the conditionsof the study not asensitizer |
| ISO 10993-5:2009 biologicalevaluation of medical devices- part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929mouse fibroblasts cells usingelution method. | Under the conditionsof study non cytotoxic | Under the conditionsof the study.cytotoxic.Additional testingwas performed todetermine if thiswas a systemictoxicity concern. |
| ISO 10993-11:2017 biologicalevaluation of medical devices- part 11, tests for systemictoxicity. | To determine the acutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inswiss Albino mice. | Under the conditionsof study the deviceextracts do notpose a systemictoxicity concern | Under the conditionsof study the deviceextracts do notpose asystemictoxicity concern |
8. Discussion of Clinical Tests Performed:
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9. Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed 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.