Powdered Free Sterile Natural Rubber Latex Surgical Gloves

K230832 · The Egyptian Company For Medical & Electronic Industries · KGO · Aug 16, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230832
• Device Name: Powdered Free Sterile Natural Rubber Latex Surgical Gloves
• Applicant: The Egyptian Company For Medical & Electronic Industries
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended 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.

Device Story

Sterile, single-use, non-pyrogenic surgical gloves made of natural rubber latex; textured palm surface; available in sizes 7, 7.5, 8, and 8.5. Used by operating room personnel to protect surgical wounds from contamination. EO sterilized to SAL 10^-6. Device provides a physical barrier between the clinician's hands and the surgical site. Performance verified through bench testing for physical properties, biocompatibility, and sterility.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM and ISO standards for dimensions, physical properties (tensile strength, elongation), watertightness (ASTM D5151), residual powder (ASTM D6124), protein content (ASTM D5712), and biocompatibility (ISO 10993 series for sensitization, irritation, systemic toxicity, and hemolysis).

Technological Characteristics

Material: Natural rubber latex (Type 1 per ASTM D3577-09). Form factor: Sterile, powder-free, textured palm. Dimensions: Length 265mm (min), thickness 0.10mm (min). Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Connectivity: None. Software: None.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Suitable for use by clinicians in general and plastic surgery settings.

Regulatory Classification

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.

Predicate Devices

• Disposable Sterilized Latex Surgical Gloves (K211953)

Submission Summary (Full 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 ([e-mail]) or phone [phone] 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: [phone] Email: alaa.elsayed(@emiegypt.com Type of 510(k) Submission: traditional

Contact person: Alaa Elsayed Email: [e-mail] 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<br>(K211953) | Discussion |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Device name | Powdered Free Sterile Natural<br>Rubber Latex Surgical Gloves | Disposable sterilized latex<br>surgical gloves | |
| Manufacturer | Egyptian company for medical<br>& electronic industries EMI | Jiangxi Kemei Medical<br>Apparatus & Instruments<br>Group Co., Ltd | |
| Device classification<br>name | surgeon's gloves | surgeon's gloves | Same |
| FDA regulation number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification Product<br>Code | KGO | KGO | Same |
| FDA classification | I | I | Same |
| Regulation medical<br>specialty | General& plastic surgery | General& plastic surgery | Same |
| Classification as per<br>ASTMD3577-09,<br>Standard Specification<br>for Rubber Surgical<br>Glove | Type 1 - gloves compounded<br>primarily from natural rubber<br>latex, | Type 1 - gloves compounded<br>primarily from natural rubber<br>latex, | Same |
| 510k review panel | General hospital | General hospital | Same |
| FDA identification | A non-powdered surgeon's glove<br>is a device intended to be worn on<br>the hands of operating room<br>personnel to protect a surgical<br>wound from contamination. A<br>non-powdered surgeon's glove<br>does not incorporate powder for<br>purposes other than<br>manufacturing. The final finished<br>glove includes only residual<br>powder from manufacturing | A non-powdered surgeon's glove<br>is a device intended to be worn<br>on the hands of operating room<br>personnel to protect a surgical<br>wound from contamination. A<br>non-powdered surgeon's glove<br>does not incorporate powder for<br>purposes other than<br>manufacturing. The final<br>finished glove includes only<br>residual powder from<br>manufacturing | Same |
| Description | Sterile Powder free, surgical<br>gloves are made of natural<br>Rubber latex. The gloves are<br>provided in Sizes 7.0, 7.5, 8.0<br>and 8.5 | A non-powdered surgeon's glove<br>is made of natural rubber latex,<br>per standard ASTM D3577-<br>09(15), the rubber surgical<br>gloves classification is: "Type 1-<br>gloves compounded primarily<br>from nature rubber latex." The<br>gloves are powder-free and<br>available in white in sizes 6, 6.5,<br>.7, 7.5, 8, and 8.5 | The sizes within<br>the<br>Range of the<br>predicate<br>device |
| Material | Natural rubber | Natural rubber | Same |
| Indications for use<br>statement | The powdered free sterile natural<br>rubber latex surgical gloves are<br>device made of natural rubber<br>intended to be worn by operating<br>room personnel to protect a<br>surgical wound from<br>contamination. | The Disposable Sterilized Latex<br>Surgical Glove is a device made<br>of nature rubber intended to be<br>worn by operating room<br>personnel to protect a surgical<br>wound from contamination | Same |
| Powdered/<br>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 within<br>the<br>range of the<br>predicate<br>device |
| Dimensions | Length:<br>Size 7: 265 mm, min<br>Size 7.5: 265 mm, min<br>Size 8: 265 mm, min<br>Size 8.5: 265 mm, min | Length:<br>Size 6: 265mm, min<br>Size 6.5: 265mm, min<br>Size 7: 265mm, min<br>Size 7.5: 265mm, min<br>Size 8: 265mm, min<br>Size 8.5: 265mm, min | |
| | Width:<br>Size 7: 89 $\pm$ 6 mm<br>Size 7.5:95 $\pm$ 6 mm<br>Size 8: 102 $\pm$ 6 mm<br>Size 8.5: 108 $\pm$ 6 mm | Width:<br>Size 6: 76 $\pm$ 6 mm<br>Size 6.5: 83 $\pm$ 6 mm<br>Size 7: 89 $\pm$ 6 mm<br>Size 7.5: 95 $\pm$ 6 mm<br>Size 8: 102 $\pm$ 6 mm<br>Size 8.5: 108 $\pm$ 6 mm | Same<br>Meeting<br>requirement<br>of ASTM<br>D 3577 |
| | Palm thickness: 0.10 mm, min<br>Finger thickness: 0.10 mm, min<br>Cuff thickness:0.10 mm, min | Palm Thickness: 0.10mm, min<br>Finger Thickness: 0.10mm, min<br>Cuff 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 /<br>non pyrogenic | Non pyrogenic | Non pyrogenic | Same | | |
| Material-mediated<br>pyrogenicity | 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 systemic<br>toxicity. | No evidence of acute systemic<br>toxicity. | 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)<br>AQL 1.5 | Meets ASTM D5151-06(2015)<br>AQL 1.5 | Same | | |
| Protein Content | Meets ASTM D5712-15(2020) | Meets ASTM D5712-15(2020) | Same | | |
| Powdered residue | Meets ASTM D6124-<br>06 (Reapproved 2017) | Meets ASTM D6124-<br>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-<br>09(Reapproved 2015)<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To determine the<br>length of the gloves | 265mm, min | pass |
| | ASTM D3577-<br>09(Reapproved<br>2015)Standard<br>Specification for<br>Rubber Surgical Gloves | To determine the<br>width of the gloves | Size 7: 89 ± 6 mm<br>Size 7.5: 95 ± 6 mm<br>Size 8: 102 ± 6 mm<br>Size 8.5: 108 ± 6 mm | pass |
| | ASTM D3577-<br>09(Reapproved 2015)<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To determine the<br>thickness of the<br>gloves | Palm: 0.10mm, min<br>Finger: 0.10 mm, min<br>Cuff: 0.10mm, min | pass |
| Physical Properties | ASTM D3577-<br>09(Reapproved 2015)<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To Determine the<br>physical properties<br>Tensile strength | Before Ageing<br>Tensile Strength 24Mpa<br>Minimum for all sizes<br>After Ageing<br>Tensile Strength 18Mpa<br>Minimum for all sizes | pass |
| | ASTM D3577-<br>09(Reapproved 2015)<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To Determine the<br>physical properties<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>750% Min for all sizes<br>After Ageing<br>Ultimate Elongation<br>560% Min for all sizes | pass |
| | ASTM D3577-<br>09(Reapproved 2015)<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To Determine the<br>physical properties<br>stress at 500 % | 5.5 Mpa, Max | pass |
| Watertight test | ASTM D5151-19<br>Standard Test Method<br>for Detection of<br>Holes in Medical<br>Gloves | To determine the<br>water tightness of the<br>test gloves | AQL 1.5 | pass |
| Residual powder | ASTM D6124-06<br>(Reapproved 2017)<br>Standard Test Method<br>for Residual Powder<br>on Medical Gloves | To determine the<br>residual powder in<br>the gloves | 2 mg per glove or less | pass |
| Protein content | ASTM D5712 - 15,<br>Standard Test Method<br>for Analysis of<br>Aqueous Extractable<br>Protein in Natural<br>Rubber. | To determine the<br>extractable protein in<br>the gloves. | 50 µg/ dm² Max for all<br>sizes | pass |
| Skin Sensitization | ISO 10993-10<br>Biological Evaluation<br>of Medical Devices<br>Test for Irritation and<br>Skin Sensitization.<br>Test done for irritation | The test was designed<br>to evaluate the<br>potential of a test<br>article to cause skin<br>sensitization. | Under the conditions of<br>the study, not a<br>sensitizer | pass |
| Irritation | ISO 10993-10<br>Biological Evaluation<br>of Medical Devices<br>Test for Irritation and<br>Skin Sensitization.<br>Test done for irritation | To evaluate the<br>potential skin<br>irritation caused by<br>test article contact<br>with the skin surface<br>of rabbits. | Under the condition of<br>study, not an irritant | pass |
| Acute Systemic<br>toxicity | ISO 10993-11:2017<br>biological evaluation of<br>medical devices - part<br>11, tests for systemic<br>toxicity | The test article was<br>evaluated to<br>determine whether<br>leachable extracted<br>from the test article<br>would cause acute<br>systemic toxicity<br>following injection<br>into mice. | Under the conditions of<br>study, the device extracts do<br>not pose an acute systemic<br>toxicity concern | pass |
| Material mediated<br>pyrogenicity | Japanese Pharmacopeia<br>Rabbit Pyrogen Test | The test article was<br>evaluated to determine<br>the risk of febrile<br>reaction in rabbits<br>following intravenous<br>injection. | Under the conditions of the<br>study, non- pyrogenic | pass |
| Hemolysis test | ANSI/AAMI/ISO<br>10993-4:2017 | The test article was<br>assessed to determine<br>whether the test article<br>would cause hemolysis<br>in vitro by direct contact<br>method. | Under the conditions of the<br>study, non-hemolytic | pass |
| Bacterial Endotoxin | USP 43 <85><br>Bacterial Endotoxin<br>Test | Bacterial Endotoxin<br>Test | <20 EU/ pair of gloves | pass |
| EO Residue | ISO 10993-7:2008 | Determine if the<br>Ethylene Oxide<br>residues of test article<br>is within the<br>requirements. | Not more than<br>4mg/device | pass |
| ECH Residue | ISO 10993-7:2008 | Ethylene<br>Chlorohydrin level<br>determination | Not more than<br>9mg/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.