(131 days)
Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.
The document provided is a 510(k) premarket notification for "Latex Examination Powder Free Gloves." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data against established standards for medical gloves, rather than clinical studies using AI.
Therefore, the requested information regarding AI study details (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, how ground truth for training was established) is not applicable to this submission, as it does not involve an AI/ML powered device.
However, I can extract the acceptance criteria and device performance based on the non-clinical tests described.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method & Purpose | Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| ASTM D3578-05 (Reapproved 2015) - Length | Min 230 mm for all sizes | X-Small: 236 mm, Small: 236 mm, Medium: 242 mm, Large: 248 mm, X-Large: 252 mm |
| ASTM D3578-05 (Reapproved 2015) - Width | X-Small: 70+/-10 mm, Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 111+/-10 mm, X-Large: 115+/-10 mm | X-Small: 76 mm, Small: 85 mm, Medium: 98 mm, Large: 106 mm, X-Large: 116 mm |
| Physical Properties | ||
| ASTM D3578-05 (Reapproved 2015) - Thickness | Palm: 0.08 mm min, Finger: 0.08 mm min for all sizes | All sizes (X-Small to X-Large): Palm 0.12 mm, Finger 0.14 mm |
| ASTM D3578-05 (Reapproved 2015) - Tensile Strength (Before Ageing) | 18 Mpa Min for all sizes | X-Small: 22.08 Mpa, Small: 22.16 Mpa, Medium: 22.22 Mpa, Large: 22.30 Mpa, X-Large: 22.32 Mpa |
| ASTM D3578-05 (Reapproved 2015) - Tensile Strength (After Ageing) | 14 Mpa Min for all sizes | X-Small: 18.50 Mpa, Small: 18.56 Mpa, Medium: 18.65 Mpa, Large: 18.74 Mpa, X-Large: 18.76 Mpa |
| ASTM D3578-05 (Reapproved 2015) - Ultimate Elongation (Before Ageing) | 650% Min for all sizes | X-Small: 856%, Small: 868%, Medium: 874%, Large: 880%, X-Large: 882% |
| ASTM D3578-05 (Reapproved 2015) - Ultimate Elongation (After Ageing) | 500% Min for all sizes | X-Small: 842%, Small: 850%, Medium: 855%, Large: 860%, X-Large: 862% |
| ASTM D3578-05 (Reapproved 2015) - Stress at 500% Elongation (Before Ageing) | 5.5 Mpa Max for all sizes | X-Small: 5.1 Mpa, Small: 5.1 Mpa, Medium: 5.2 Mpa, Large: 5.2 Mpa, X-Large: 5.2 Mpa |
| Barrier Integrity | ||
| ASTM D5151-06 (Reapproved 2015) - Detection of Holes (Water Tight) | AQL 2.5 | Gloves Pass AQL 1.5 |
| Other Properties | ||
| ASTM D6124-06 (Reapproved 2017) - Residual Powder on Medical Gloves | 2 Mg/Glove Max | X-Small: 0.21 mg/glove, Small: 0.21 mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove |
| ASTM D5712-95 (Reapproved 2010) - Analysis of Protein in Natural Rubber | 200 µg/dm² Max for all sizes | All sizes (X-Small to X-Large): 32 µg/dm² |
| ISO 10993-10:2010(E) - Primary Skin Irritation | Not an irritant | Under the condition of study, not an irritant |
| ISO 10993-10:2010(E) - Dermal Sensitization | Not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009(E) - In vitro cytotoxicity | Non-cytotoxic | Under the conditions of the study, non-cytotoxic |
| ISO 10993-11:2017(E) / USP - Material mediated Pyrogenicity | Non-pyrogenic | Under the conditions of the study, non-pyrogenic |
| USP 42 <85> - Bacterial Endotoxin Test | <20 EU/pair of gloves (implied, based on comparison table data) | <20 EU/pair of gloves |
| ISO 10993-11:2017(E) - Acute Systemic Toxicity Test | Not systemic toxic | 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 (e.g., country of origin of the data, retrospective or prospective)
- The document describes a series of non-clinical, controlled laboratory tests performed according to ASTM and ISO standards for medical gloves. Specific sample sizes for each test are not explicitly stated in the provided summary, beyond the "AQL 1.5" for water tightness (which relates to the acceptable quality level for sampling, not the total sample size tested).
- Data provenance: The tests were conducted to specific international and US standards (ASTM, ISO, USP). The manufacturing entity, Aspen Glove Sdn. Bhd., is based in Malaysia, suggesting the tests were likely performed in or commissioned by the manufacturer within that region, or by certified testing labs. The data is prospective for the purpose of demonstrating the device meets the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This is a non-AI device. Ground truth in this context refers to the defined scientific and engineering standards (e.g., ASTM, ISO) and the results of laboratory measurements against those standards. The "experts" are the qualified laboratory personnel conducting the tests and interpreting the results according to the test methodologies. The document does not specify the number or qualifications of these testing personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. This is a non-AI device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers to establish consensus ground truth for complex interpretations (e.g., medical image diagnosis). For physical and chemical tests, the results are objectively measured against established criteria.
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 a non-AI device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a non-AI device. "Standalone" performance testing refers to the evaluation of an AI algorithm without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" is defined by the established performance specifications and methodologies outlined in the referenced standards (ASTM, ISO, USP). The device's characteristics (length, width, tensile strength, elongation, thickness, powder residue, extractable protein, biocompatibility, water tightness, bacterial endotoxin) are quantitatively measured and compared against the predefined numerical or qualitative acceptance criteria from these standards.
8. The sample size for the training set
- Not Applicable. This is a non-AI device and does not involve machine learning training sets.
9. How the ground truth for the training set was established
- Not Applicable. This is a non-AI device and does not have a "training set" or corresponding ground truth establishment process in the context of AI.
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September 20, 2021
Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Mangement Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K211477
Trade/Device Name: Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 16, 2021 Received: August 16, 2021
Dear Manoj Zacharias:
We have reviewed vour 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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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 531-542 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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical And Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211477
Device Name
Latex Examination Powder Free Gloves
Indications for Use (Describe)
Latex Examination Powder Free Gloves are disposable device intended for medical purpose 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) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY
As required by 21CFR§807.92(c)
A. APPLICANT INFORMATION
| Applicant | Aspen Glove Sdn. Bhd. |
|---|---|
| Address | Aspen House, 300, JLN Macalister,10450 Georgetown, Pulau Pinang,Malaysia |
| Phone | +604- 227 5000 |
| Fax | +604- 227 5000 |
| corporate@aspen.com.my | |
| Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| Designation | Managing Director |
| Contact Number | 017 -550 0577 |
| Contact Email | Iskandar@aspenglove.com.my |
| Date Submitted | APRIL 25th, 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Latex Examination Powder Free Gloves |
|---|---|
| Product proprietary ortrade name | AspenPro+ |
| Common or usual name | Latex Examination Powder Free Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class I |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Legally Marketed devicesthat Equivalency is claimed | JR Medic Powder free Latex Examination Gloves |
|---|---|
| 510(K) Number | K192329 |
| Regulatory Class | Class I |
| Product code | LYY |
D. DESCRIPTION OF THE DEVICE:
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.
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E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:
Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
F. TECHNOLOGICAL CHARACTERISTICS
| Characteristics | Standards | Device Performance | Comparison | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate | Current | |||||||||||||||
| 510(K) Number | --- | K192329 | K211477 | --- | ||||||||||||
| Name of device | --- | JR MEDICBlue LatexExaminationPowder FreeGloves | Latex ExaminationPowder Free Gloves | --- | ||||||||||||
| Dimensions-Length | ASTMD3578-05(Reapproved2015) | Length > 230 mm | Length > 230 mm | Similar | ||||||||||||
| Size Average X-Small 236 Small 236 Medium 242 Large 248 X-Large 252 | ||||||||||||||||
| Dimensions- Width | ASTMD3578-05(Reapproved2015) | Width Min 95+/-10 mm (formedium size) | Width Min 95+/-10mm (for medium size) | Similar | ||||||||||||
| Size Average X-Small 76 Small 85 Medium 98 Large 106 X-Large 116 | ||||||||||||||||
| PhysicalProperties-TensileStrength | ASTMD3578-05(Reapproved2015) | Before AgeingTensile Strength> 18 Mpa | Before AgeingTensile Strength > 18 Mpa | Similar | ||||||||||||
| Size Actual value X-Small 22.08 Small 22.16 Medium 22.22 Large 22.30 X-Large 22.32 | ||||||||||||||||
| After AgeingTensileStrength> 14 Mpa | After AgeingTensile Strength > 14 Mpa | Similar | ||||||||||||||
| Size Actual value X-Small 18.50 Small 18.56 Medium 18.65 Large 18.74 X-Large 18.76 |
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| Characteristics | Standards | Device Performance | Comparison | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate | Current | |||||||||||||||||||||
| 510(K) Number | K192329 | |||||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTMD3578-05(Reapproved 2015) | Before AgeingUltimate Elongation> 650% | Before AgeingUltimate Elongation > 650%Size Actual value X-Small 856 Small 868 Medium 874 Large 880 X-Large 882 | Similar | ||||||||||||||||||
| After AgeingUltimate Elongation>500% | After AgeingUltimate Elongation > 500%Size Actual value X-Small 842 Small 850 Medium 855 Large 860 X-Large 862 | |||||||||||||||||||||
| Thickness | ASTMD3578-05(Reapproved 2015) | Palm > 0.08 mmFinger > 0.08 mm | Palm > 0.08 mmFinger > 0.08 mmSize Palm(Actual value) Finger(Actual value) X-Small 0.12 0.14 Small 0.12 0.14 Medium 0.12 0.14 Large 0.12 0.14 X-Large 0.12 0.14 | Similar | ||||||||||||||||||
| Powder Free Residue | ASTMDD 3578-10(Reapproved 2015) | <2 mg/glove | <2 mg/gloveSize Residual powder content (mg/glove) X-Small 0.21 Small 0.21 Medium 0.22 Large 0.22 X-Large 0.22 | Similar | ||||||||||||||||||
| Biocompatibility | Primary SkinIrritation-ISO10993-10:2010(E) | Under the conditionof study, not anirritant | Under the condition of studynot an irritant | Same | ||||||||||||||||||
| DermalSensitization-ISO10993-10:2010(E) | Under the conditionsof the study, not asensitizer | Under the conditions of thestudy, not a sensitizer | Same | |||||||||||||||||||
| In vitro cytotoxicityISO10993-5:2009(E) | Under the conditionsof the study,non-cytotoxic | Under the conditions of thestudy, non-cytotoxic | Same | |||||||||||||||||||
| Material mediatedPyrogenicityISO 10993-11:2017(E) / USP | Under theconditions of thestudy non pyrogenic | Under the conditions of thestudy, non-pyrogenic | Same |
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| Characteristics | Standards | Device Performance Predicate | Current | Comparison |
|---|---|---|---|---|
| 510(K) Number | K192329 | ---- | ||
| Biocompatibility | Bacterial Endotoxin testUSP 42<85> | No data available | <20EU/pair of gloves | ---- |
| Acute Systemic Toxicity Test ISO 10993-11:2017(E) | Under the condition of study not systemic toxic | Under the conditions of study the device extracts do not pose a systemic toxicity concern | same | |
| Water Tight (1000 ml) | ASTM D5151-06 (Reapproved 2015) | Passes AQL-1.5 | Passes AQL-1.5 | Same |
| Intended use | JR MEDIC Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are won on the examiner's hand to prevent contamination between patient and examiner. | Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are won on the examiner's hand to prevent contamination between patient and examiner. | Same | |
| Material | - | Natural Latex | Natural Latex | Identical |
| Color | - | Blue | Natural (No color is added) | different |
| Texture | - | Finger Texture | Finger texture | Identical |
| Size | ASTMD 3578-5 (Reapproved 2015) | Small, Medium, Large & X Large | X Small, Small, Medium, Large, X-Large | Similar |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non Sterile | Non Sterile | Same |
| Powder/Powder free | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Label requirements | Meets FDA's label and labeling requirements | Meets FDA's label and labeling requirements | Same |
| Manufacturer(s) | - | JR Engineering & Medical Technologies (M) SDN BHD | Aspen Glove Sdn. Bhd. | --- |
G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ASTM D3578-05 (Reapproved 2015)Standard Specification for RubberExamination Gloves | To determine the length ofthe gloves | Min 230 mm for all sizes | X-Small 236 mmSmall 236 mmMedium 242 mmLarge 248 mmX-Large 252 mm |
| ASTM D3578-05 (Reapproved 2015)Standard Specification for RubberExamination Gloves | To determine the width ofthe gloves | X-Small 70+/-10 mmSmall 80+/-10mmMedium 95+/-10 mmLarge 111+/-10 mmX-Large 115+/-10 mm | X-Small 76 mmSmall 85 mmMedium 98 mmLarge 106 mmX-Large 116 mm |
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| Test Method | Purpose | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|
| ASTMD3578-05(Reapproved 2015) StandardSpecification for RubberExamination Gloves | To determine the thickness ofthe gloves | Palm 0.08 mm minFinger 0.08 mm minfor all sizes | SizeX-SmallSmallMediumLargeX-Large | Palm Finger0.12mm 0.14mm0.12mm 0.14mm0.12mm 0.14mm0.12mm 0.14mm0.12mm 0.14mm | |
| ASTMD3578-05(Reapproved 2015) StandardSpecification for RubberExamination Gloves | To Determine the physicalproperties-Tensile strength | Before AgeingTensile Strength18Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing Afterageing22.08 Mpa 18.50 Mpa22.16 Mpa 18.56 Mpa22.22 Mpa 18.65 Mpa22.30 Mpa 18.74 Mpa22.32 Mpa 18.76 Mpa | |
| ASTMD3578-05(Reapproved 2015) StandardSpecification for RubberExamination Gloves | To Determine the physicalproperties-Ultimate Elongation | Before AgeingUltimate Elongation650% Min for allsizesAfter AgeingUltimate Elongation500% Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing Afterageing856% 842%868% 850%874% 855%880% 860%882% 862% | |
| To Determine the physicalproperties-stress at 500%Elongation | Before Ageing5.5 Mpa Max for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing5.1 Mpa5.1 Mpa5.2 Mpa5.2 Mpa5.2 Mpa | NA | |
| ASTMD5151-06(Reapproved 2015) StandardTest Method for Detection ofHoles in Medical Gloves | To determine the holes in thegloves | AQL 2.5 | Gloves Passes AQL 1.5 | ||
| ASTMD6124-06(Reapproved 2017) StandardTest Method for ResidualPowder on Medical Gloves | To determine the residualpowder in the gloves | 2 Mg/Glove Max | SizeX-SmallSmallMediumLargeX-Large | Residual PowderContent0.21 mg/glove0.21 mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove | |
| ASTM D5712-95 ( Reapproved 2010) Standard TestMethod for the Analysis ofProtein in Natural Rubber | To determine the extractableprotein in the gloves. | 200 µg/ dm² Max forall sizes | SizeX-SmallSmallMediumLargeX-Large | ExtractableProtein content32 µg/ dm²32 µg/ dm²32 µg/ dm²32 µg/ dm²32 µg/ dm² |
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The performance test data of the non-clinical tests meet following standards:
-
ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves
-
ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
-
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
-
ASTM D5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
H. CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Latex Examination Powder Free Gloves is as effective, and performs as well as or better than the legally marketed predicate device K192329.
§ 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.