(85 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 D3578-2019, 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 and Non-Sterile.
The provided document describes the FDA 510(k) premarket notification for "Latex Examination Powder Free Gloves." This is a Class I medical device, which typically does not require a complex AI/algorithm-based study with human readers, ground truth establishment by experts, or MRMC studies. The approval is based on demonstrating substantial equivalence to a predicate device through non-clinical performance data against established industry standards.
Therefore, many of the requested elements for describing AI acceptance criteria and study methodology (like sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this type of device and submission.
The document explicitly states "H. SUMMARY OF CLINICAL TESTING: Not applicable." This reinforces that the submission did not rely on clinical performance data involving human readers or sophisticated AI algorithms.
However, I can extract the acceptance criteria and performance data as presented for these gloves.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Latex Examination Powder Free Gloves" are based on established ASTM (American Society for Testing and Materials) standards for rubber examination gloves. The table below summarizes these criteria and the reported performance of the device (K222348) compared to the predicate device (K192329).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics / Test Method | Standard / Purpose | Acceptance Criteria (K192329 Predicate) | Reported Device Performance (K222348 - Current Device) | Comparison |
|---|---|---|---|---|
| Dimensions - Length (ASTM D3578-2019) | To determine the length of the gloves | > 230 mm (all sizes) | > 230 mm (Actual values: X-Small 305 mm, Small 306 mm, Medium 307 mm, Large 308 mm, X-Large 310 mm) | Similar |
| Dimensions - Width (ASTM D3578-2019) | To determine the width of the gloves | Min 95+/-10 mm (for medium size) | X-Small 76 mm, Small 85 mm, Medium 96 mm, Large 106 mm, X-Large 116 mm | Similar |
| Physical Properties - Tensile Strength (ASTM D3578-2019) | To Determine the physical properties | Before Ageing: > 18 Mpa (all sizes)After Ageing: > 14 Mpa (all sizes) | Before Ageing: X-Small 22.07 Mpa, Small 22.15 Mpa, Medium 22.22 Mpa, Large 22.30 Mpa, X-Large 22.32 MpaAfter Ageing: X-Small 18.49 Mpa, Small 18.56 Mpa, Medium 18.67 Mpa, Large 18.74 Mpa, X-Large 18.76 Mpa | Similar |
| Physical Properties - Ultimate Elongation (ASTM D3578-2019) | To Determine the physical properties | Before Ageing: > 650% (all sizes)After Ageing: > 500% (all sizes) | Before Ageing: X-Small 858%, Small 869%, Medium 874%, Large 880%, X-Large 882%After Ageing: X-Small 841%, Small 848%, Medium 854%, Large 860%, X-Large 862% | Similar |
| Thickness (ASTM D3578-2019) | To determine the thickness of the gloves | Palm > 0.08 mm, Finger > 0.08 mm (all sizes) | Palm: 0.16mm (all sizes)Finger: 0.22mm (all sizes) | Similar |
| Powder Free Residue (ASTM D6214) | To determine the residual powder in the gloves | ≤ 2 mg/glove | 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 | Similar |
| Protein Content (ASTM D5712) | To determine the extractable protein in the gloves | Max 200 µg/dm² | 43.19 µg/dm² (reported as 43.65 µg/dm² for all sizes in detailed results) | Similar |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010) | Not specified in detail, but expected to ensure safe contact with skin. | Under the condition of study, not an irritant | Under the condition of study, not an irritant | Same |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010) | Not specified in detail, but expected to ensure safe contact with skin. | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility - In vitro cytotoxicity (ISO 10993-5:2009) | Not specified in detail, but expected to ensure no toxic effects on cells. | Under the conditions of the study, cytotoxic (This might be a typo and should be "not cytotoxic", or it implies a specific acceptable level of cytotoxicity.) | Under the conditions of the study, cytotoxic (As above, likely implies within acceptable limits for the device type, or a typo). | Same |
| Biocompatibility - Acute Systemic Toxicity Test (ISO 10993-11:2017) | Not specified in detail, but expected to ensure no systemic toxic effects. | Device extracts do not pose a systemic toxicity concern | Device extracts do not pose a systemic toxicity concern | Same |
| Water Tightness (ASTM D5151-2019) | To determine the holes in the gloves | AQL 2.5 | Passes AQL 1.5 (AQL 1.5 is a tighter requirement than AQL 2.5, indicating better performance) | Same |
| Material-mediated Pyrogenicity (ISO 10993-11:2017 / USP 41<151>) | To ensure the material does not cause fever. | Under the conditions of the study, non-pyrogenic | No data available (for the current device in this specific row, but typically expected for such devices. May be covered by general biocompatibility; the predicate was non-pyrogenic). | ---- |
| Intended use/Indication for use | JR MEDIC Blue 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. | JR MEDIC Blue 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. | 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. | Similar |
| Material | - | Natural Latex | Natural Latex | Same |
| Color | - | Blue | Natural (No color is added) | Different |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D3578-2019 | Small, Medium, Large & X Large | X Small, Small, Medium, Large, X-Large (Added X-Small size) | 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 |
Study Details (Applicable to this Device Type)
Given this is a 510(k) for examination gloves, the "study" is a series of non-clinical, laboratory tests performed according to specific ASTM and ISO standards, rather than a clinical trial or an AI algorithm performance study.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, width, or tensile strength). However, it implies that standard testing methodologies as defined by ASTM and ISO were followed. These standards usually specify the number of samples required for each test. The data provenance is from JR Engineering & Medical Technologies (M) SDN.BHD., Malaysia, indicating the tests were conducted by the manufacturer or a contracted lab in Malaysia. The data is non-clinical performance data, reported as part of a premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device is physical and chemical adherence to specific measurable standards (e.g., a glove is X mm long, has Y tensile strength), not a diagnostic interpretation requiring expert medical opinion. The standards themselves, like ASTM D3578-2019, serve as the "ground truth" for performance.
4. Adjudication Method for the Test Set:
Not applicable. This is not a human-interpreted diagnostic task requiring adjudication. The tests are objective measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this was not done. MRMC studies are typically for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) on clinical cases is evaluated. This device is an examination glove.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an AI algorithm. Its performance is measured through physical and chemical properties.
7. The Type of Ground Truth Used:
The ground truth used is objective engineering and material science standards (e.g., ASTM D3578-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-95, ISO 10993 series). These are internationally recognized standards for manufacturing and safety.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI device trained on a dataset. The "training" for such a device would be the manufacturing process development and quality control to ensure consistency.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as it's not an AI training set. The "ground truth" for manufacturing would be the specifications and quality control procedures adherence to ensure gloves meet the physical and chemical standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2022
JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K222348
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: September 28, 2022 Received: September 28, 2022
Dear Manoj Zacharias:
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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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.
Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222348
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
K22348
As required by 21CFR§807.92(c)
A. APPLICANT INFORMATION
| Applicant | JR Engineering & Medical Technologies (M) SDN.BHD. |
|---|---|
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, PusatPerindustrian 2, 44200 Rasa, Hulu Selangor, Selangor Darul Ehsan,Malaysia. |
| Phone | +603-60572081 |
| Fax | +603-60572181 |
| ganeshjrmt@gmail.com | |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | +6012 224 6677 |
| Contact Email | ganeshjrmt@gmail.com |
| Date Submitted | 27 October 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Latex Examination Powder Free Gloves |
|---|---|
| Product proprietary ortrade name | JR MEDIC |
| 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 devices | JR Medic Powder free Latex Examination Gloves |
|---|---|
| that Equivalency is claimed | |
| 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 D3578-2019, 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 and Non-Sterile.
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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.
Device Performance Characteristics Standards Comparison Predicate Current K192329 K222348 510(K) Number ---Name of device JR MEDIC Blue Latex Examination ---Latex Powder Free Gloves Examination Powder Free Gloves Dimensions-Length > 230 mm Length > 230 mm ASTM Length D3578-2019 Size Average X-Small 305 Small 306 Medium 307 Large 308 X-Large 310 Dimensions- Width Width Min 95+/-ASTM Width Min 95+/-10 D3578-2019 10 mm (for mm (for medium medium size) size) Siz Average e X-Small 76 Small 82 Medium 96 Large 1 06 X-Large 116 Physical Before Ageing ASTM Before Ageing Properties-D3578-2019 Tensile Strength Tensile Strength > 18 Mpa Tensile > 18 Mpa Siz Actual Strength value e X-Small 22.07 Small 22.15 22.22 Medium Large 22.30 22.32 X-Large After Ageing After Ageing Tensile Tensile Strength > 14 Mpa Strength
14 Mpa
F. TECHNOLOGICAL CHARACTERISTICS
Similar
Similar
Similar
Similar
Siz
e
X-Small
Medium
X-Large
Small
Large
Actual
value
18.49
18:56
18.67
18.74
18.76
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| Characteristics | Standards | Device Performance | Comparison | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate | Current | |||||||||||||||||||||
| 510(K) Number | K192329 | K222348 | ||||||||||||||||||||
| PhysicalProperties-UltimateElongation | ASTMD3578-2019 | Before AgeingUltimateElongation> 650% | Before AgeingUltimate Elongation > 650% | Similar | ||||||||||||||||||
| Size Actual value X-Small 858 Small 869 Medium 874 Large 880 X-Large 882 | ||||||||||||||||||||||
| After AgeingUltimateElongation>500% | After AgeingUltimate Elongation > 500% | |||||||||||||||||||||
| Size Actual value X-Small 841 Small 848 Medium 854 Large 860 X-Large 862 | ||||||||||||||||||||||
| Thickness | ASTMD3578-2019 | Palm > 0.08 mmFinger > 0.08 mm | Palm > 0.08 mmFinger > 0.08 mm | Similar | ||||||||||||||||||
| Size Palm(Actualvalue) Finger(Actualvalue) X-Small 0.16 0.22 Small 0.16 0.22 Medium 0.16 0.22 Large 0.16 0.22 X-Large 0.16 0.22 | ||||||||||||||||||||||
| Powder FreeResidue | ASTM D6214 | ≤2 mg/glove | ≤2 mg/glove | Similar | ||||||||||||||||||
| Size Residualpowder content(mg/glove) X-Small 0.21 Small 0.21 Medium 0.22 Large 0.22 X-Large 0.22 | ||||||||||||||||||||||
| Protein Content | ASTM D5712 | Max 200 µg/ dm2 | 43.19 µg/ dm2 | Similar | ||||||||||||||||||
| Biocompatibility | Primary SkinIrritation-ISO10993-10:2010(E) | Under the conditionof study, not anirritant | Under the condition of studynot an irritant | Same | ||||||||||||||||||
| Dermal Sensitization-ISO 10993-10:2010(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,cytotoxic | Under the conditions of thestudy, cytotoxic | Same | |||||||||||||||||||
| Material mediatedPyrogenicityISO 1099311:2017(E)/ USP 41<151> | Under theconditions of thestudy non | No data available | ---- |
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| Characteristics | Standards | Device Performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| 510(K) Number | K192329 | K222348 | ||
| Biocompatibility | Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Under the conditionsof study the device extractsdo not pose a systemictoxicity concern | same |
| Water Tight(1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Same |
| Intended use/Indication for use | JR MEDIC Blue LatexExamination PowderFree Gloves aredisposable devicesintended for medicalpurpose that are wonon the examiner'shand to preventcontaminationbetween patient andexaminer. | Latex Examination PowderFree Gloves are disposabledevices intended for medicalpurpose that are worn on theexaminer's hand to preventcontamination betweenpatient and examiner. | Similar | |
| Material | - | Natural Latex | Natural Latex | Same |
| Color | - | Blue | Natural (No color is added) | different |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D3578-2019 | Small, Medium, Large& X Large | X Small, Small,Medium, Large, X-Large | Similar |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powderfree | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Labelrequirements | Meets FDA's labeland labelingrequirements | Meets FDA's labeland labelingrequirements | Same |
| Manufacturer(s) | - | JR Engineering &Medical Technologies(M) SDN.BHD.Malaysia | JR Engineering & MedicalTechnologies (M) SDN.BHD.Malaysia | Same |
G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result | |
|---|---|---|---|---|
| ASTM D3578-2019 StandardSpecification for Rubber ExaminationGloves | To determine thelength of the gloves | Min 230 mm for all sizes | X-Small 305 mmSmall 306 mmMedium 307 mmLarge 308 mmX-Large 310 mm | |
| ASTM D3578-2019 StandardSpecification for Rubber ExaminationGloves | To determine the widthof the gloves | X-Small 70+/-10 mmSmall 80+/-10mmMedium 95+/-10 mmLarge 111+/-10 mmX-Large 115+/-10 mm | X-Small 76 mmSmall 85 mmMedium 96 mmLarge 106 mmX-Large 116 mm | |
| Test Method | Purpose | Acceptance Criteria | Result | |
| ASTM D3578-2019 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 Finger0.16mm 0.22mm0.16mm 0.22mm0.16mm 0.22mm0.16mm 0.22mm0.16mm 0.22mm |
| ASTM D3578-2019Standard Specification forRubber Examination Gloves | To Determine the physicalproperties-Tensile strength | Before AgeingTensile Strength18Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Before ageing After ageing22.07 Mpa 18.49 Mpa22.15 Mpa 18.56 Mpa22.22 Mpa 18.67 Mpa22.30 Mpa 18.74 Mpa22.32 Mpa 18.76 Mpa |
| ASTM D3578-2019Standard Specification forRubber Examination Gloves | To Determine the physicalproperties-Ultimate Elongation | Before AgeingUltimate Elongation650% Min for allsizesAfter AgeingUltimate Elongation500% Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Before ageing After ageing858% 841%869% 848%874% 854%880% 860%882% 862% |
| To Determine the physicalproperties-stress at 500%Elongation | Before Ageing5.5 Mpa Max for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing NA5.1 Mpa5.1 Mpa5.2 Mpa5.2 Mpa5.2 Mpa | |
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine the holes in thegloves | AQL 2.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06(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 D 5712-95 ( 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 content43.65 µg/dm²43.65 µg/dm²43.65 µg/dm²43.65 µg/dm²43.65 µg/dm² |
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The performance test data of the non-clinical tests meet following standards:
- A ASTMD 3578-2019 Standard Specification for Rubber Examination Gloves
- ASTMD 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves >
-
ASTMD 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
-
ASTMD 5712-95 (Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
H. SUMMARY OF CLINICAL TESTING
Not applicable
I. 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.