(142 days)
The powdered free sterile natural rubber latex surgical gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The device is a sterile, single-use, non-pyrogenic, latex surgical glove. The proposed device is made of natural rubber latex. Per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from natural rubber latex." The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The gloves are powdered free and available in four sizes 7, 7.5, 8, 8.5 to be suitable for user's hand. The Glove palm has textured surface.
The provided text is a 510(k) Summary for a medical device: "Powdered Free Sterile Natural Rubber Latex Surgical Gloves." This document describes the device, its intended use, and comparative non-clinical performance testing against a predicate device to demonstrate substantial equivalence.
It does not describe:
- An AI/ML-driven device.
- A study proving an AI/ML meets acceptance criteria.
- Any ground truth establishment or expert adjudication.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Training set details.
Therefore,Based on the provided FDA 510(k) Summary for "Powdered Free Sterile Natural Rubber Latex Surgical Gloves," the document does not describe an AI/ML-driven device or any study related to AI/ML performance.
The 510(k) submission focuses on demonstrating substantial equivalence of the surgical gloves to a predicate device through non-clinical performance testing. The information requested in the prompt, such as acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment, are not applicable to the content of this document, as it pertains to a physical medical device (surgical gloves) and not a software algorithm or AI.
Therefore, I cannot extract the requested information from the provided text.
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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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 16, 2023
The Egyptian Company For Medical & Electronic Industries Alaa Elsayed General Manager Industrial Zone 7. Part 7062A&B Sadat City, Monofeya Egypt
Re: K230832
Trade/Device Name: Powdered Free Sterile Natural Rubber Latex Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: July 14, 2023 Received: July 14, 2023
Dear Alaa Elsayed:
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,
Allan Guan -S
For Bifeng Qian, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230832
Device Name
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
Indications for Use (Describe)
The powdered free sterile natural rubber latex surgical gloves 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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510(k) Summary (K230832)
(As required by 21 CFR 807.92)
I. SUBMITTER INFORMATION
Egyptian company for medical & electronic industries EMI Address: Sadat City-Industrial Zone7.Part 7062A&B-Monofeya, Egypt Phone: +201000080166 Email: alaa.elsayed(@emiegypt.com Type of 510(k) Submission: traditional
Contact person: Alaa Elsayed Email: alaa.elsayed@emiegypt.com Tel: + 201000080166 Date updated: 16/08/2023
II. DEVICE
Name of Device: Powdered Free Sterile Natural Rubber Latex Surgical Gloves Regulation medical specialty: general and plastic surgery Review panel: general hospital Common or Usual Name: Non-powdered surgeon's glove Classification Name: Non-powdered surgeon's glove. Product Code: KGO Regulation number: 21CFR 878 . 4460 Device Class: I 510(k) Number: K230832
III. PREDICATE DEVICE
510(k) Number: K211953 Clearing date: 25/05/2022 Product Name: Disposable Sterilized Latex Surgical Gloves Submitter: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd Product Code: KGO Regulation number: 21CFR 878 . 4460 Device Class: I
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IV. DEVICE DESCRIPTION
The device is a sterile, single-use, non-pyrogenic, latex surgical glove.
The proposed device is made of natural rubber latex. Per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from natural rubber latex." The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 10-6.
The gloves are powdered free and available in four sizes 7, 7.5, 8, 8.5 to be suitable for user's hand.
The Glove palm has textured surface.
V. INDICATIONS FOR USE
The powdered free sterile natural rubber latex surgical gloves 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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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Item | Subject device | Predicate device(K211953) | Discussion |
|---|---|---|---|
| Device name | Powdered Free Sterile NaturalRubber Latex Surgical Gloves | Disposable sterilized latexsurgical gloves | |
| Manufacturer | Egyptian company for medical& electronic industries EMI | Jiangxi Kemei MedicalApparatus & InstrumentsGroup Co., Ltd | |
| Device classificationname | surgeon's gloves | surgeon's gloves | Same |
| FDA regulation number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification ProductCode | KGO | KGO | Same |
| FDA classification | I | I | Same |
| Regulation medicalspecialty | General& plastic surgery | General& plastic surgery | Same |
| Classification as perASTMD3577-09,Standard Specificationfor Rubber SurgicalGlove | Type 1 - gloves compoundedprimarily from natural rubberlatex, | Type 1 - gloves compoundedprimarily from natural rubberlatex, | Same |
| 510k review panel | General hospital | General hospital | Same |
| FDA identification | A non-powdered surgeon's gloveis a device intended to be worn onthe hands of operating roompersonnel to protect a surgicalwound from contamination. Anon-powdered surgeon's glovedoes not incorporate powder forpurposes other thanmanufacturing. The final finishedglove includes only residualpowder from manufacturing | A non-powdered surgeon's gloveis a device intended to be wornon the hands of operating roompersonnel to protect a surgicalwound from contamination. Anon-powdered surgeon's glovedoes not incorporate powder forpurposes other thanmanufacturing. The finalfinished glove includes onlyresidual powder frommanufacturing | Same |
| Description | Sterile Powder free, surgicalgloves are made of naturalRubber latex. The gloves areprovided in Sizes 7.0, 7.5, 8.0and 8.5 | A non-powdered surgeon's gloveis made of natural rubber latex,per standard ASTM D3577-09(15), the rubber surgicalgloves classification is: "Type 1-gloves compounded primarilyfrom nature rubber latex." Thegloves are powder-free andavailable in white in sizes 6, 6.5,.7, 7.5, 8, and 8.5 | The sizes withintheRange of thepredicatedevice |
| Material | Natural rubber | Natural rubber | Same |
| Indications for usestatement | The powdered free sterile naturalrubber latex surgical gloves aredevice made of natural rubberintended to be worn by operatingroom personnel to protect asurgical wound fromcontamination. | The Disposable Sterilized LatexSurgical Glove is a device madeof nature rubber intended to beworn by operating roompersonnel to protect a surgicalwound from contamination | Same |
| Powdered/powdered free | Powdered free | Powdered free | Same |
| Color | Natural (no color is added) | White | Same |
| Sizes | 7, 7.5, 8 and 8.5 | 6, 6.5, 7, 7.5, 8 and 8.5 | The sizes withintherange of thepredicatedevice |
| Dimensions | Length:Size 7: 265 mm, minSize 7.5: 265 mm, minSize 8: 265 mm, minSize 8.5: 265 mm, min | Length:Size 6: 265mm, minSize 6.5: 265mm, minSize 7: 265mm, minSize 7.5: 265mm, minSize 8: 265mm, minSize 8.5: 265mm, min | |
| Width:Size 7: 89 $\pm$ 6 mmSize 7.5:95 $\pm$ 6 mmSize 8: 102 $\pm$ 6 mmSize 8.5: 108 $\pm$ 6 mm | Width:Size 6: 76 $\pm$ 6 mmSize 6.5: 83 $\pm$ 6 mmSize 7: 89 $\pm$ 6 mmSize 7.5: 95 $\pm$ 6 mmSize 8: 102 $\pm$ 6 mmSize 8.5: 108 $\pm$ 6 mm | SameMeetingrequirementof ASTMD 3577 | |
| Palm thickness: 0.10 mm, minFinger thickness: 0.10 mm, minCuff thickness:0.10 mm, min | Palm Thickness: 0.10mm, minFinger Thickness: 0.10mm, minCuff Thickness: 0.10mm, min | ||
| Single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | Same |
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| Packaging | Packed 1 pair in a wallet. One wallet in a pouch. | Packed 1 pair in a wallet. One wallet in a pouch. | Same | ||
|---|---|---|---|---|---|
| Sterile or non-sterile | Sterile | Sterile | Same | ||
| Sterilization | ETO, SAL- 10-6 | ETO, SAL- 10-6 | same | ||
| Shelf life | 5 years | 3 years | Different | ||
| Pyrogenic or /non pyrogenic | Non pyrogenic | Non pyrogenic | Same | ||
| Material-mediatedpyrogenicity | No temperature rise ≥0.5°C | No temperature rise ≥0.5°C | Similar¹ | ||
| Bacterial endotoxin | <20EU/device | <20EU/device | Same | ||
| Sensitization | Non-sensitizer | Non-sensitizer | Same | ||
| Irritation | Non-irritant | Non-irritant | Same | ||
| Acute systemic toxicity | No evidence of acute systemictoxicity. | No evidence of acute systemictoxicity. | Same | ||
| Hemolytic property | Non-hemolytic | N/A | Different | ||
| Tensile strength | Before Aging | 24MPa, min | Before Aging | 24MPa, min | Same |
| After Aging | 18MPa, min | After Aging | 18MPa, min | ||
| Ultimate Elongation | Before Aging | 750%, min | Before Aging | 750%, min | Same |
| After Aging | 560%, min | After Aging | 560%, min | ||
| Freedom from holes | Meets ASTM D5151-06(2015)AQL 1.5 | Meets ASTM D5151-06(2015)AQL 1.5 | Same | ||
| Protein Content | Meets ASTM D5712-15(2020) | Meets ASTM D5712-15(2020) | Same | ||
| Powdered residue | Meets ASTM D6124-06 (Reapproved 2017) | Meets ASTM D6124-06 (Reapproved 2017) | Same | ||
| EtO and ECH residuals | Meets ISO 10993-7:2008 | Meets ISO 10993-7:2008 | Same |
'The subject device was tested for material pyrogenicity per the Japanese Pharmacopeia Rabbit Pyrogen Test whereas the predicate was tested using USP<151>. However, testing was equivalent.
VII. SUMMARY OFNONCLINICAL PERFORMANCE TESTING
The gloves were tested according to the following standards:
- ASTM D5151-19 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 D3577-19 Standard Specification for Rubber Surgical Gloves
- ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural ● Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
- ISO 10993-1:2018 Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- USP 43 <85> Bacterial Endotoxin Test
- Japanese Pharmacopeia Rabbit Pyrogen Test ●
- ANSI/AAMI/ISO 10993-4:2017: Hemolysis testing ●
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| Test method | standard | Test procedure | Criteria | Result |
|---|---|---|---|---|
| Dimension | ASTM D3577-09(Reapproved 2015)Standard Specificationfor Rubber SurgicalGloves | To determine thelength of the gloves | 265mm, min | pass |
| ASTM D3577-09(Reapproved2015)StandardSpecification forRubber Surgical Gloves | To determine thewidth of the gloves | Size 7: 89 ± 6 mmSize 7.5: 95 ± 6 mmSize 8: 102 ± 6 mmSize 8.5: 108 ± 6 mm | pass | |
| ASTM D3577-09(Reapproved 2015)Standard Specificationfor Rubber SurgicalGloves | To determine thethickness of thegloves | Palm: 0.10mm, minFinger: 0.10 mm, minCuff: 0.10mm, min | pass | |
| Physical Properties | ASTM D3577-09(Reapproved 2015)Standard Specificationfor Rubber SurgicalGloves | To Determine thephysical propertiesTensile strength | Before AgeingTensile Strength 24MpaMinimum for all sizesAfter AgeingTensile Strength 18MpaMinimum for all sizes | pass |
| ASTM D3577-09(Reapproved 2015)Standard Specificationfor Rubber SurgicalGloves | To Determine thephysical propertiesUltimate Elongation | Before AgeingUltimate Elongation750% Min for all sizesAfter AgeingUltimate Elongation560% Min for all sizes | pass | |
| ASTM D3577-09(Reapproved 2015)Standard Specificationfor Rubber SurgicalGloves | To Determine thephysical propertiesstress at 500 % | 5.5 Mpa, Max | pass | |
| Watertight test | ASTM D5151-19Standard Test Methodfor Detection ofHoles in MedicalGloves | To determine thewater tightness of thetest gloves | AQL 1.5 | pass |
| Residual powder | ASTM D6124-06(Reapproved 2017)Standard Test Methodfor Residual Powderon Medical Gloves | To determine theresidual powder inthe gloves | 2 mg per glove or less | pass |
| Protein content | ASTM D5712 - 15,Standard Test Methodfor Analysis ofAqueous ExtractableProtein in NaturalRubber. | To determine theextractable protein inthe gloves. | 50 µg/ dm² Max for allsizes | pass |
| Skin Sensitization | ISO 10993-10Biological Evaluationof Medical DevicesTest for Irritation andSkin Sensitization.Test done for irritation | The test was designedto evaluate thepotential of a testarticle to cause skinsensitization. | Under the conditions ofthe study, not asensitizer | pass |
| Irritation | ISO 10993-10Biological Evaluationof Medical DevicesTest for Irritation andSkin Sensitization.Test done for irritation | To evaluate thepotential skinirritation caused bytest article contactwith the skin surfaceof rabbits. | Under the condition ofstudy, not an irritant | pass |
| Acute Systemictoxicity | ISO 10993-11:2017biological evaluation ofmedical devices - part11, tests for systemictoxicity | The test article wasevaluated todetermine whetherleachable extractedfrom the test articlewould cause acutesystemic toxicityfollowing injectioninto mice. | Under the conditions ofstudy, the device extracts donot pose an acute systemictoxicity concern | pass |
| Material mediatedpyrogenicity | Japanese PharmacopeiaRabbit Pyrogen Test | The test article wasevaluated to determinethe risk of febrilereaction in rabbitsfollowing intravenousinjection. | Under the conditions of thestudy, non- pyrogenic | pass |
| Hemolysis test | ANSI/AAMI/ISO10993-4:2017 | The test article wasassessed to determinewhether the test articlewould cause hemolysisin vitro by direct contactmethod. | Under the conditions of thestudy, non-hemolytic | pass |
| Bacterial Endotoxin | USP 43 <85>Bacterial EndotoxinTest | Bacterial EndotoxinTest | <20 EU/ pair of gloves | pass |
| EO Residue | ISO 10993-7:2008 | Determine if theEthylene Oxideresidues of test articleis within therequirements. | Not more than4mg/device | pass |
| ECH Residue | ISO 10993-7:2008 | EthyleneChlorohydrin leveldetermination | Not more than9mg/device | pass |
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VIII. SUMMARY OF CLINICAL TESTING
No clinical testing is included in this submission.
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IX. CONCLUSIONS
The conclusions drawn from the non-clinical tests demonstrate that the subject device, powdered Free Sterile Natural Rubber Latex Surgical Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K211953.
§ 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).