(104 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, Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterilized 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. 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 either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 +and place in a sterility maintenance package to ensure a shelf life of 3 years.
This document is a 510(k) premarket notification for a medical device: "Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein)".
The acceptance criteria and study proving the device meets those criteria are detailed through non-clinical testing against established ASTM and ISO standards for surgical gloves.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| Criteria | Specification (Acceptance Criteria per ASTM D3577-09 Standard) | Reported Device Performance (Average Value of Subject Device) | Device Complied? |
|---|---|---|---|
| Length | Min 265mm | ||
| Size 5'2 | Min 265mm | 281 mm | Yes |
| Size 6 | Min 265mm | 281mm | Yes |
| Size 6'2 | Min 265mm | 282mm | Yes |
| Size 7 | Min 265mm | 282mm | Yes |
| Size 7'2 | Min 265mm | 282mm | Yes |
| Size 8 | Min 265mm | 283mm | Yes |
| Size 8'2 | Min 265mm | 283mm | Yes |
| Size 9 | Min 265mm | 283mm | Yes |
| Width | |||
| Size 5'2 | 70+/-6mm | 74mm | Yes |
| Size 6 | 76+/-6mm | 78mm | Yes |
| Size 6'2 | 83+/-6mm | 84mm | Yes |
| Size 7 | 89+/-6mm | 91mm | Yes |
| Size 7'2 | 95+/-6mm | 97mm | Yes |
| Size 8 | 102+/-6mm | 103mm | Yes |
| Size 8'2 | 108+/-6mm | 109mm | Yes |
| Size 9 | 114+/-6mm | 115mm | Yes |
| Finger Thickness (All) | Min 0.10mm | 0.18mm | Yes |
| Palm Thickness (All) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (All) | Min 0.10mm | 0.13mm | Yes |
| Tensile Strength | |||
| Before aging (All) | 24Mpa minimum | 28.0Mpa | Yes |
| After aging (All) | 18Mpa minimum | 24.0Mpa | Yes |
| Ultimate Elongation | |||
| Before aging (All) | 750% minimum | 920% | Yes |
| After aging (All) | 560% minimum | 750% | Yes |
| Stress at 500% (All) | 5.5 MPa Max | 3 Mpa | Yes |
| Pinhole AQL | |||
| Before aging (All) | Max 1.5 | 1.0 | Yes |
| After aging (All) | Max 1.5 | 1.0 | Yes |
| Powder Content | < 2 mg/Glove (for powder free gloves) | Not explicitly stated as value but "Yes" to compliance | Yes |
| Protein Content | <= 50 µg/dm² (labeling claim) | Not explicitly stated as value but "Yes" to compliance | Yes |
| Biocompatibility | Non-irritant and Non-Sensitizer | Non-irritant and Non-Sensitizer | Yes |
2. Sample sizes used for the test set and the data provenance:
The document describes non-clinical bench testing according to specific ASTM and ISO standards. While the results (average values) are presented, the exact sample sizes used for each physical and chemical test are not explicitly detailed in this document. The provenance of the data is from the manufacturer's internal testing as part of their 510(k) submission, implied to be prospective testing for regulatory compliance. The manufacturer is Beta Healthcare Products Pvt. Ltd. from Kerala, India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical bench testing. Therefore, no human experts were involved in establishing "ground truth" in the way one would for diagnostic imaging studies. The "ground truth" or acceptance criteria are defined by established international standards (ASTM D3577-09, ASTM D5151-2011, ASTM D6124-2011, ASTM D5712-10, ASTM D6499-12, ASTM F1929-2004, ISO 10993-10:2010, ISO 11137-2:2013, ISO 10993-7:2008, ISO 11135-1:2007). Performance is measured against these universally accepted benchmarks.
4. Adjudication method for the test set:
Not applicable. This is not a human interpretation study. The compliance is determined by objective physical and chemical measurements against pre-defined standard specifications.
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 document pertains to the regulatory clearance of surgical gloves, which are physical medical devices, not AI/software as a medical device (SaMD). Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software.
7. The type of ground truth used:
The "ground truth" for the performance evaluation are established international standards and specifications (e.g., ASTM D3577-09 for physical properties, ASTM D5151-2011 for pinholes, ISO 10993-10 for biocompatibility). The device performance is measured against these objective, scientifically validated standards.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/machine learning model. There is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there's no training set, there's no ground truth for it. The ground truth for the device's performance, as stated in point 7, is based on adherence to recognized industry standards.
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January 8, 2018
Beta Healthcare Products Pvt. Ltd. % Manoj Zacharias President Liberty Management Group Ltd 75 Executive Dr., Ste 114 Aurora, Illinois 60504
Re: K172942
Trade/Device Name: Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: November 29, 2017 Received: December 5, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172942
Device Name
Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein)
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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K172942
PAGE NO -1
510K SUMMARY as required by: 21CFR § 807.92 A. APPLICANT INFORMATION
| 1. | Submitter Name | Beta Healthcare Products Pvt.Ltd. |
|---|---|---|
| Date Submitted | November 29, 2017 | |
| Address | Plot No 21B,Cochin Special Economic Zone,Kakkanad,Kochi-682037.Kerala, India. | |
| Phone | +91 484 2413389 , 2413390 | |
| Fax | +91 484 2413341 | |
| betahealthcare@gmail.com | ||
| Contact Person | Boney Moolayil | |
| Designation | Director | |
| Contact Number | +91 974700797 | |
| Contact Email | betahealthcare@gmail.com |
B. US AGENT & CONTACT PERSON INFORMATION
| 17 | US agent & contact person name | Manoj Zacharias |
|---|---|---|
| 18 | Address | Liberty Management Group Ltd.75 Executive Dr, STE 114, Aurora, IL-60504, USA. |
| 19 | Phone | (630) 270-2921 |
| 20 | Fax | (815) 986-2632 |
| 21 | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| Common Name | Surgeon's Glove |
|---|---|
| Device Name | Surgeon's Glove powder free |
| Product proprietary or trade name | Pristeen (Latex Surgeon's GlovesPowder Free, Polymer coated withprotein content labeling claim of 50µg/dm² or less per glove ofextractable protein) |
| Classification name | Surgeon's Glove |
| Device Classification | 1 |
| Product Code | KGO |
| Regulation Number | 21 CFR 878.4460 |
| Review Panel | Gen & Plastic Surgery |
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K172942
PAGE NO -2
D.PREDICATE DEVICE INFORMATION
| Sl.No | Name of devices | 510k Number | 510K Owner |
|---|---|---|---|
| Predicate device-1 | Medismart+ Latex Surgeon'sGlove powder free-polymercoated with protein contentlabeling claim of 50 $ \u00b5g $ /dm² orless per glove of extractableprotein | K151114 | St.Marys Rubbers Pvt.Ltd.Koovappally P.O,Kanjirappally, KottayamDistrict, Kerala State, India-686518 |
| Predicate device-2 | SURGTEX Latex Surgeon'sGlove powder free-polymercoated with protein contentlabeling claim of 50 $ \u00b5g $ /dm² orless per glove of extractableprotein | K130450 | Purna Bina SDN BHDPlo 5, Jalan Mahsuri, 7.5km,Jalan Mersing,Kluang Industrial AreaKluang, Johor 86000 |
E. DESCRIPTION OF THE DEVICE
The proposed device, Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterilized 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
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 either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 +and place in a sterility maintenance package to ensure a shelf life of 3 years.
F. INDICATIONS FOR USE STATEMENT:
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.
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K172942
PAGE NO - 3
G. NON-CLINICAL TEST CONCLUSION
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-09:- Standard Specification for Rubber Surgical Gloves.
ASTM D 5151-2011:-Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-2011:- Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-10:-Standard Test Method for the Analysis of Aqueous Extractable Protein in NaturalRubber and Its Products Using the Modified Lowry Method.
ASTM D6499-12:-Standard Test Method for the Immunological Measurement of Antigenic Proteinin Natural Rubber and Its Products.
ASTM F 1929-2004:- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
1S01137-2: 2013. Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
ISO 10993-7:2008:-Biological evaluation of medical devices -: Ethylene oxide sterilization residuals
ISO 11135-1:2007 :- Sterilization of healthcare products -- Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
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K172942
PAGE NO -4
H. PRODUCT COMPARISON IN COMPLIANCE WITH ASTM D 3577-09 STANDARD
SIZES AVAILABLE: - 5'/2, 6, 6'/2, 7, 7'/2, 8, 8'/2, 9
| SL.NO | CRITERIA | SPECIFICATION ASPER ASTMD3577-09STANDARD | AVERAGE VALUE OFSUBJECT DEVICE | WHETHER SUBJECTDEVICE COMPLIEDWITH THEASTMD3577 -09STANDARD |
|---|---|---|---|---|
| 1 | Length | |||
| Size 5′/2 | Min 265mm | 281 mm | Yes | |
| Size 6 | Min 265mm | 281mm | Yes | |
| Size 6′/2 | Min 265mm | 282mm | Yes | |
| Size 7 | Min 265mm | 282mm | Yes | |
| Size 7′/2 | Min 265mm | 282mm | Yes | |
| Size 8 | Min 265mm | 283mm | Yes | |
| Size 8′/2 | Min 265mm | 283mm | Yes | |
| Size 9 | Min 265mm | 283mm | Yes | |
| 2 | Width | |||
| Size 5′/2 | 70+/-6mm | 74mm | Yes | |
| Size 6 | 76+/-6mm | 78mm | Yes | |
| Size 6′/2 | 83+/-6mm | 84mm | Yes | |
| Size 7 | 89+/-6mm | 91mm | Yes | |
| Size 7′/2 | 95+/-6mm | 97mm | Yes | |
| Size 8 | 102+/-6mm | 103mm | Yes | |
| Size 8′/2 | 108+/-6mm | 109mm | Yes | |
| Size 9 | 114+/-6mm | 115mm | Yes | |
| 3 | Finger Thickness(All sizes) | Min 0.10mm | 0.18mm | Yes |
| 4 | Palm Thickness(All sizes) | Min 0.10mm | 0.16mm | Yes |
| 5 | Cuff Thickness(All sizes) | Min 0.10mm | 0.13mm | Yes |
| SL.NO | CRITERIA | SPECIFICATION ASPER ASTMD3577-09STANDARD | AVERAGE VALUEOF SUBJECTDEVICE | WHETHER SUBJECTDEVICE COMPLIEDWITH THE ASTMD3577-09 STANDARD |
| 6 | Tensile Strength | |||
| Before aging(All sizes) | 24Mpa minimum | 28.0Mpa | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 18Mpa minimum | 24.0Mpa | Yes | |
| 7 | Ultimate Elongation | |||
| Before aging(All sizes) | 750% minimum | 920% | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 560% minimum | 750% | Yes | |
| 8 | Stress at 500%before ageing(All sizes) | 5.5 MPa Max | 3 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 |
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PAGE NO - 5
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K172942
PAGE NO - 6
I. SUBSTANTIAL EQUIVALENCE COMPARISON
General Characteristics Comparison a.
| Characteristic | Subject deviceK172942 | Predicate device-1K151114 | Predicate device-2K130450 | SubstantiallyEquivalent(SE) or Not(NSE) |
|---|---|---|---|---|
| Product Code | KGO | KGO | KGO | SE |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | SE |
| Class | 1 | 1 | 1 | SE |
| Intended Use forLatex Surgeon'sGloves PowderFree, Polymercoated withprotein contentlabeling claim of50 $\mu$ g/dm² or lessper glove ofextractableprotein. | A latex surgeon's glove is adevice made of natural rubberintended to be worn byoperating room personnel toprotect a surgical wound fromcontamination. | A latex surgeonSurgeons glove isa device made ofnatural rubberintended to beworn by operatingroom personnel toprotect a surgicalwound fromcontamination | A latex surgeonSurgeons glove isa device made ofnatural rubberintended to beworn by operatingroom personnel toprotect a surgicalwound fromcontamination - | Substantiallyequivalent |
| Powdered orPowder free | powered free | Powdered, andpowered free | powered free | SE |
| Classification perASTMD3577-99 | Type I - gloves compoundedprimarily from natural rubberlatex | Type I - glovescompoundedprimarily fromnatural rubberlatex | Type I - glovescompoundedprimarily fromnatural rubberlatex | SE |
| Sterilization | ETO/as well as Radiation,SAL- 10-6 | ETO/as well asRadiation,SAL- 10-6 | RadiationSAL: 10-6 | SE |
| Label andLabeling | Meet FDA's Requirements | Meet FDA'sRequirements | Meet FDA'sRequirements | SE |
| Special labelclaim | Protein content labeling claimof 50 $\mu$ g/dm² or less per gloveof extractable protein for LatexSurgeon's GlovesPowderFree, Polymer coated | Same | same | SE |
| Type of use | Over the counter use | Over the counteruse | Over the counteruse | SE |
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K172942
PAGE NO - 7
b. Technological Characteristics Comparison
| Characteristics | Acceptance criteria of the standard | Whether thesubject devicemet theacceptancecriteria of thestandard | ||
|---|---|---|---|---|
| Subject deviceK172942 | Predicate device-1K151114 | Predicate device-2K130450 | ||
| Dimensions | ASTM D3577-09(published date02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| PhysicalProperties | ASTM D3577-09(published date02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| Freedom fromHoles | ASTM D3577 andAST M D5151,(publisheddate 08/20/2012) | ASTM D3577 andAST M D5151 | ASTM D3577 andAST M D5151 | Yes |
| Powder Contentfor powderedglove | ASTM D3577 and ASTMD6124,(published date08/20/2012) | ASTM D3577 andASTM D6124 | ASTM D3577 andASTM D6124 | Yes |
| Powder Contentfor powder freeglove | ASTM D3577 and ASTMD6124,(published date08/20/2012)Powder content < 2mg/Glove | ASTM D3577 andASTM D6124,Powder content < 2mg/Glove | ASTM D3577 andASTM D6124,Powder content <2 mg/Glove | Yes |
| Protein Content | ASTM D3577, ASTMD5712-10 and ASTMD6499(published date02/01/2009) | ASTM D3577,ASTM D5712-10and ASTM D6499 | ASTM D3577,ASTM D5712-10and ASTM D6499 | Yes |
| Biocompatibility | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | Yes, Non-irritant and Non-Sensitizer |
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K172942
PAGE NO - 8
There is no difference with predicate device.
Substantial equivalence based on non clinical performance data
The performance test data of the non clinical tests are the same as mentioned immediately above.
Substantial equivalence based on clinical performance data.
Clinical data was not required for this submission.
Substantial Equivalence 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 devices identified in this submission (K151114 and K130450).
§ 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).