(196 days)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, JR Medic Latex Surgeon's Gloves Sterile Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white. The proposed device is sterilized using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
The provided document describes the acceptance criteria and a study proving that JR MEDIC Latex Surgeon's Gloves Sterile Powder Free meet these criteria.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Specification per ASTM D3577-09) | Reported Device Performance (Average Value) | Compliance |
|---|---|---|---|
| Length (for all sizes) | Min 265mm | 305mm - 306mm | Yes |
| Width | |||
| Size 6 | 76+/-6mm | 78mm | Yes |
| Size 6 1/2 | 83+/-6mm | 85mm | Yes |
| Size 7 | 89+/-6mm | 88mm | Yes |
| Size 7 1/2 | 95+/-6mm | 97mm | Yes |
| Size 8 | 102+/-6mm | 103mm | Yes |
| Size 8 1/2 | 108+/-6mm | 110mm | Yes |
| Size 9 | 114+/-6mm | 116mm | Yes |
| Thickness (for all sizes) | |||
| Finger Thickness | Min 0.10mm | 0.21mm | Yes |
| Palm Thickness | Min 0.10mm | 0.18mm | Yes |
| Cuff Thickness | Min 0.10mm | 0.11mm | Yes |
| Tensile Strength (Before aging) | 24Mpa minimum | 26.0Mpa | Yes |
| Tensile Strength (After aging Pinhole AQL) | 18Mpa minimum | 22.0Mpa | Yes |
| Ultimate Elongation (Before aging) | 750% minimum | 860% | Yes |
| Ultimate Elongation (After aging Pinhole AQL) | 560% minimum | 725% | Yes |
| Stress at 500% (before aging) | 5.5 MPa Max | 2.7 Mpa | Yes |
| Pinhole AQL (Before aging) | Max 1.5 | 1.0 | Yes |
| Pinhole AQL (After aging) | Max 1.5 | 1.0 | Yes |
| Powder content | < 2 mg/Glove | 0.34 mg/Glove | Yes |
| Protein Content | < 50 µg/dm² | 43 µg/dm² | Yes |
| Biocompatibility - Irritation & Sensitization | Non-irritant and Non-Sensitizer | Non-irritant and Non-Sensitizer | Yes (Same) |
| Biocompatibility - Cytotoxicity | (Implied: Non-cytotoxic, as the predicate is) | Cytotoxic | No (Different - but accepted by FDA as part of substantial equivalence) |
| Biocompatibility - Systemic Toxicity | (Implied: No systemic toxicity) | No systemic toxicity under the conditions of the test | Yes |
| Pyrogen Test | Non-pyrogenic | Non-pyrogenic | Yes (Same) |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 | Yes |
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 does not explicitly state the sample size for each specific test within the non-clinical performance data. It indicates "Average value of subject device" for each criterion, implying that multiple units were tested. The data provenance is from JR Engineering & Medical Technologies (M) SDN.BHD., which is located in Malaysia. The study is a non-clinical bench test study to verify that the device meets design specifications, and therefore, the terms retrospective or prospective don't directly apply in the same way they would for a clinical study with human subjects.
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)
This section is not applicable as the study is a non-clinical bench test for physical and chemical properties of gloves. "Experts" in this context would likely be laboratory technicians or engineers performing standardized tests, rather than medical experts establishing a ground truth for diagnostic purposes. The ground truth is established by the specifications in recognized standards like ASTM and ISO.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the tests are objective measurements against established standards, not subjective assessments requiring adjudication.
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
This is not applicable. The device is a surgical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for a surgical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the acceptance criteria is based on recognized international standards and specifications for medical devices, specifically:
- ASTM D3577-09(15): Standard Specification for Rubber Surgical Gloves.
- ASTM D 5151-06 (2015): Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (2017): Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D5712-15: Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
- ASTM D6499-18: Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
- ASTM F 1929-2015: Standard Test Method for Detecting Seal Leaks in Porous Packaging by Dye Penetration.
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity and Biological Tests.
- USP 41 <151> Pyrogen Test.
- ISO 11137-1-2006/ (R) 2010 - validation of sterilization process.
- ISO 11137-2:2013, sterilization of health care products - radiation - part 2: establishing the sterilization dose.
8. The sample size for the training set
This is not applicable as this is a non-clinical bench test for a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 10, 2020
JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr, STE 114 Aurora, Illinois 60504
Re: K192328
Trade/Device Name: JR MEDIK Latex Surgeon's Gloves Sterile Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: February 12, 2020 Received: February 14, 2020
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.
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
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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 (OS) 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 Elizabeth Claverie, M.S. 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) K192328
Device Name
JR Medic Latex Surgeon's Gloves Sterile Powder Free
Indications for Use (Describe)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510K SUMMARY
K192328
as required by: 21 CFR § 807.92
A. APPLICANT INFORMATION
| Submitter Name | JR Engineering & Medical Technologies (M)SDN.BHD. |
|---|---|
| Date Submitted | 24th Nov 2019 |
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1 & 3, Jalan Zurah 3A/1Pusat Perindustrian 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 |
B. US AGENT & CONTACT PERSON INFORMATION
| US agent & contact person name | Manoj Zacharias |
|---|---|
| Address | Liberty Management Group Ltd.2871, Coastal Dr. Aurora, IL-60503, USA |
| Phone | (630) 270-2921 |
| Fax | (815) 986-2632 |
| manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| Common Name | Surgeon's Gloves |
|---|---|
| Device Name | Surgeon's Gloves powder free |
| Product proprietaryor trade name | JR MEDIC LATEX SURGEON'S GLOVES STERILE POWDER FREE |
| Classification name | Surgeon's Gloves |
| Device Classification | I |
| Product Code | KGO |
| Regulation Number | 21 CFR 878.4460 |
| Review Panel | General Hospital |
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D.PREDICATE DEVICE INFORMATION
| Device | Name of device | 510k Number | 510K Owner |
|---|---|---|---|
| Predicatedevice | Pristeen Latex Surgeon's Glovespowder free with protein contentlabeling claim of 50 $\mu g/dm^2$ or lessper glove of extractable protein | K172942 | Beta Healthcare ProductsPvt.Ltd, Plot No 21B,Cochin Special EconmicZone, Kakkanad, Kerala,India-682037. |
| Referencedevice | Medismart+ Latex Surgeon'sGloves powder with protein contentlabeling claim of 50$\mu g/dm^2$ or less per glove ofextractable protein | K151114 | St.Marys Rubbers Pvt.Ltd,Koovappally P.O,Kanjirappally, KottayamDistrict, Kerala State,India-686518 |
E. DESCRIPTION OF THE DEVICE
The proposed device, JR Medic Latex Surgeon's Gloves Sterile Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white.
The proposed device is sterilized using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
F. INDICATION FOR USE
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
G. TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
a. General Characteristics Comparison
| Characteristic | Subject deviceK192328 | Predicate deviceK172942 | comparison |
|---|---|---|---|
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | I | I | Same |
| Intended Use | A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination | A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination | Similar |
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| Powdered orPowder free | powered free | powered free | Same |
|---|---|---|---|
| CompoundingClassification | Type I - gloves compoundedprimarily from natural rubberlatex | Type I - gloves compoundedprimarily from natural rubber latex | Same |
| Sterilization | Radiation,SAL- 10-6 | ETO/as well asRadiation, SAL- 10-6 | Different |
| Labeling | Meet FDA's labelRequirements | Meet FDA's labelRequirements | Same |
| Special labelclaim | Protein content labeling claim of50µg/dm² or less | Protein content labeling claim of50µg/dm² or less | Same |
| Type of use | Over the counter use | Over the counter use | Same |
b. Technological Characteristics Comparison
| Specification and physical properties per ASTMD3577- 09(Reapproved 2015), Standard Specificationfor Rubber Surgical Gloves. | SubjectdeviceK192328 | PredicatedeviceK172942 | Remarks | |
|---|---|---|---|---|
| Dimensions Length: Min 265 mm | 300 mm | 282 mm | Similar | |
| Width | ||||
| Size | 6.0(76+/-6mm) | 78mm | 78mm | Similar |
| 6.5(83+/-6mm) | 85mm | 84mm | ||
| 7.0(89+/-6mm) | 88mm | 91mm | ||
| 7.5(95+/-6mm) | 97mm | 97mm | ||
| 8.0(102+/-6mm) | 103mm | 103mm | ||
| 8.5(108+/-6mm) | 110mm | 109mm | ||
| 9(114+/-6mm) | 116mm | 115mm | ||
| Thickness for all sizes | ||||
| Cuff, Palm, Finger Tip Min 0.10 mm | Cuff- 0.11mm | Cuff- 0.13mm | Similar | |
| Palm- 0.18mm | Palm-0.16mm | |||
| Finger Tip-0.21mm | Finger Tip-0.18mm | |||
| Physical Properties Before Ageing -for all sizes | ||||
| Tensile Strength 24Mpa minimum | 26.0Mpa | 28.0Mpa | Similar | |
| Ultimate Elongation 750% minimum | 860% | 920% | ||
| Stress at 500% 5.5 MPa Max | 2.7 Mpa | 3 Mpa | ||
| Physical Properties After Ageing -for all sizes | ||||
| Tensile Strength 18Mpa minimum | 22.0Mpa | 24.0Mpa | Similar | |
| Ultimate Elongation 560% minimum | 725% | 750% | ||
| Freedom from Holes AQL 1.5, AST M D5151-06,(2015), Standard Test Method for Detection of Holes | AQL 1.0 | AQL 1.0 | Similar |
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| in Medical Gloves | |||
|---|---|---|---|
| Powder content < 2 mg/Glove,ASTM D6124-06, (2017), Standard Test Method forResidual Powder on Medical Gloves | 0.34mg/Glove | 0.3mg/glove | Similar |
| Protein Content < 50 $\mu$ g/ dm²,ASTM D5712-15, Standard Test Method for theAnalysis of Aqueous Extractable Protein in NaturalRubber and Its Products Using the Modified LowryMethod;ASTM D6499-18, Standard Test Method for theImmunological Measurement of Antigenic Protein inNatural Rubber and Its Products | 43 $\mu$ g/ dm² | 40 $\mu$ g/ dm² | Similar |
| Biocompatibility | |||
| ISO 10993-10, Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization | Non- irritantand Non-Sensitizer | Non- irritantand Non-Sensitizer | Same |
| ISO 10993-5: 2009 (E), Biological Evaluation ofMedical Devices - Part 5-Tests for in vitro Cytotoxicity | Cytotoxic | Non cytotoxic | Different |
| ISO 10993-11: 2017(E). Biological Evaluation ofMedical Devices - Part 11, Tests for Systemic Toxicity, | No systemictoxicity underthe conditionsof the test | Not tested | Different |
| USP 41 <151> Pyrogen Test | Non pyrogenic | Non pyrogenic | same |
H. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Sl.No | Criteria | Specification as perASTMD3577-09,StandardSpecification forRubber SurgicalGloves | Average value ofsubject device | Compliance with theASTMD 3577-09,Standard Specificationfor Rubber SurgicalGloves |
|---|---|---|---|---|
| 1 | Length | |||
| Size 6 | Min 265mm | 306mm | Yes | |
| Size 6'/2 | Min 265mm | 306mm | Yes | |
| Size 7 | Min 265mm | 305mm | Yes | |
| Size 7'/2 | Min 265mm | 305mm | Yes | |
| Size 8 | Min 265mm | 305mm | Yes | |
| Size 8'/2 | Min 265mm | 305mm | Yes | |
| Size 9 | Min 265mm | 305mm | Yes |
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| 2 | Width | |||
|---|---|---|---|---|
| Size 6 | 76+/-6mm | 78mm | Yes | |
| Size 6'⁄2 | 83+/-6mm | 85mm | Yes | |
| Size 7 | 89+/-6mm | 88mm | Yes | |
| Size 7'⁄2 | 95+/-6mm | 97mm | Yes | |
| Size 8 | 102+/-6mm | 103mm | Yes | |
| Size 8'⁄2 | 108+/-6mm | 110mm | Yes | |
| Size 9 | 114+/-6mm | 116mm | Yes | |
| 3 | Finger Thickness(All sizes) | Min 0.10mm | 0.21mm | Yes |
| 4 | Palm Thickness(All sizes) | Min 0.10mm | 0.18mm | Yes |
| 5 | Cuff Thickness(All sizes) | Min 0.10mm | 0.11mm | Yes |
| SL.NO | Criteria | Specification as perASTMD3577-09StandardSpecification forRubber SurgicalGloves | Average value ofsubject device | Whether subject devicecomplied with theASTMD3577 -09,Standard Specificationfor Rubber SurgicalGloves |
|---|---|---|---|---|
| 6 | Tensile Strength | |||
| Before aging(All sizes) | 24Mpa minimum | 26.0Mpa | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 18Mpa minimum | 22.0Mpa | Yes | |
| 7 | Ultimate Elongation | |||
| Before aging(All sizes) | 750% minimum | 860% | Yes |
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| After aging@70°±2C for166±2 hr(All sizes) | 560% minimum | 725% | Yes | |
|---|---|---|---|---|
| 8 | Stress at 500%before ageing(All sizes) | 5.5 MPa Max | 2.7 Mpa | Yes |
| 9 | Pinhole AQL | |||
| Before aging(All sizes) | Max 1.5 | 1.0 | Yes | |
| After aging@70°C for 7 days(All sizes) | Max 1.5 | 1.0 | Yes |
Bench tests were conducted to verify that the proposed device met all design specifications or acceptance criteria found in the test method or standard. The test results demonstrated that the proposed device met design specifications or acceptance criteria with the following standards:
ASTM D3577-09(15):- Standard Specification for Rubber Surgical Gloves.
ASTM D 5151-06 (2015):-Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-15:-Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
ASTM F 1929-2015:- Standard Test Method for Detecting Seal Leaks in Porous Meckaging by Dye Penetration.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity and Biological Tests
USP 41 <151> Pyrogen Test
ISO 11137-1-2006/ (R) 2010 - validation of sterilization process
ISO 11137-2:2013, sterilization of health care products - radiation - part 2: establishing the sterilization dose
I. CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that. JR MEDIC Latex Surgeon's Gloves Sterile Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device K172942.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).