(142 days)
Not Found
No
The device description and performance studies focus solely on the physical and biological properties of a standard surgical glove. There is no mention of any computational analysis, image processing, or AI/ML terms.
No.
The device is a surgical glove, primarily intended to protect a surgical wound from contamination by operating room personnel. It does not directly diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination by operating room personnel. It does not gather information from the body for the purpose of diagnosis.
No
The device is a physical product (surgical gloves) made of natural rubber latex, not software. The description focuses on material properties, physical characteristics, and sterilization methods.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and sterility of a surgical glove. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies are focused on the physical integrity, biocompatibility, and sterility of the glove, not on the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.
This device is clearly a medical device intended for surgical use as a barrier, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Bacterial Endotoxin Test
- Japanese Pharmacopeia Rabbit Pyrogen Test
- ANSI/AAMI/ISO 10993-4:2017: Hemolysis testing
Key Results: All tests passed their respective criteria.
- Dimension: Length (265mm, min), Width (Size 7: 89 +/- 6 mm, Size 7.5: 95 +/- 6 mm, Size 8: 102 +/- 6 mm, Size 8.5: 108 +/- 6 mm), Thickness (Palm: 0.10mm, min; Finger: 0.10 mm, min; Cuff: 0.10mm, min) - all passed.
- Physical Properties: Tensile strength (Before Ageing 24MPa min, After Ageing 18Mpa min), Ultimate Elongation (Before Ageing 750% Min, After Ageing 560% Min), stress at 500 % (5.5 Mpa, Max) - all passed.
- Watertight test: AQL 1.5 - passed.
- Residual powder: 2 mg per glove or less - passed.
- Protein content: 50 µg/ dm² Max for all sizes - passed.
- Skin Sensitization: Under the conditions of the study, not a sensitizer - passed.
- Irritation: Under the condition of study, not an irritant - passed.
- Acute Systemic toxicity: Under the conditions of study, the device extracts do not pose an acute systemic toxicity concern - passed.
- Material mediated pyrogenicity: Under the conditions of the study, non- pyrogenic - passed.
- Hemolysis test: Under the conditions of the study, non-hemolytic - passed.
- Bacterial Endotoxin:
§ 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).
0
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
1
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
2
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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3
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
4
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.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Item | Subject device | Predicate device
(K211953) | Discussion |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Device name | Powdered Free Sterile Natural
Rubber Latex Surgical Gloves | Disposable sterilized latex
surgical gloves | |
| Manufacturer | Egyptian company for medical
& electronic industries EMI | Jiangxi Kemei Medical
Apparatus & Instruments
Group Co., Ltd | |
| Device classification
name | surgeon's gloves | surgeon's gloves | Same |
| FDA regulation number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification Product
Code | KGO | KGO | Same |
| FDA classification | I | I | Same |
| Regulation medical
specialty | General& plastic surgery | General& plastic surgery | Same |
| Classification as per
ASTMD3577-09,
Standard Specification
for Rubber Surgical
Glove | Type 1 - gloves compounded
primarily from natural rubber
latex, | Type 1 - gloves compounded
primarily from natural rubber
latex, | Same |
| 510k review panel | General hospital | General hospital | Same |
| FDA 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 | 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 | Same |
| Description | Sterile Powder free, surgical
gloves are made of natural
Rubber latex. The gloves are
provided in Sizes 7.0, 7.5, 8.0
and 8.5 | A non-powdered surgeon's glove
is made of natural rubber latex,
per standard ASTM D3577-
09(15), the rubber surgical
gloves classification is: "Type 1-
gloves compounded primarily
from nature rubber latex." The
gloves are powder-free and
available in white in sizes 6, 6.5,
.7, 7.5, 8, and 8.5 | The sizes within
the
Range of the
predicate
device |
| Material | Natural rubber | Natural rubber | Same |
| Indications for use
statement | The powdered free sterile natural
rubber latex surgical gloves are
device made of natural rubber
intended to be worn by operating
room personnel to protect a
surgical wound from
contamination. | The Disposable Sterilized Latex
Surgical Glove is a device made
of nature rubber intended to be
worn by operating room
personnel to protect a surgical
wound 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 within
the
range of the
predicate
device |
| Dimensions | Length:
Size 7: 265 mm, min
Size 7.5: 265 mm, min
Size 8: 265 mm, min
Size 8.5: 265 mm, min | Length:
Size 6: 265mm, min
Size 6.5: 265mm, min
Size 7: 265mm, min
Size 7.5: 265mm, min
Size 8: 265mm, min
Size 8.5: 265mm, min | |
| | Width:
Size 7: 89 $\pm$ 6 mm
Size 7.5:95 $\pm$ 6 mm
Size 8: 102 $\pm$ 6 mm
Size 8.5: 108 $\pm$ 6 mm | Width:
Size 6: 76 $\pm$ 6 mm
Size 6.5: 83 $\pm$ 6 mm
Size 7: 89 $\pm$ 6 mm
Size 7.5: 95 $\pm$ 6 mm
Size 8: 102 $\pm$ 6 mm
Size 8.5: 108 $\pm$ 6 mm | Same
Meeting
requirement
of ASTM
D 3577 |
| | Palm thickness: 0.10 mm, min
Finger thickness: 0.10 mm, min
Cuff thickness:0.10 mm, min | Palm Thickness: 0.10mm, min
Finger Thickness: 0.10mm, min
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 |
6
7
| 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-mediated | |||||
| pyrogenicity | No temperature rise ≥0.5°C | No temperature rise ≥0.5°C | Similar¹ | ||
| Bacterial endotoxin | . 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 Bacterial Endotoxin Test
- Japanese Pharmacopeia Rabbit Pyrogen Test ●
- ANSI/AAMI/ISO 10993-4:2017: Hemolysis testing ●
8
| Test method | standard | Test procedure | Criteria | Result |
|---|---|---|---|---|
| Dimension | ASTM D3577- | |||
| 09(Reapproved 2015) | ||||
| Standard Specification | ||||
| for Rubber Surgical | ||||
| Gloves | To determine the | |||
| length of the gloves | 265mm, min | pass | ||
| ASTM D3577- | ||||
| 09(Reapproved | ||||
| 2015)Standard | ||||
| Specification for | ||||
| Rubber Surgical Gloves | To determine the | |||
| width of the gloves | Size 7: 89 ± 6 mm | |||
| Size 7.5: 95 ± 6 mm | ||||
| Size 8: 102 ± 6 mm | ||||
| Size 8.5: 108 ± 6 mm | pass | |||
| ASTM D3577- | ||||
| 09(Reapproved 2015) | ||||
| Standard Specification | ||||
| for Rubber Surgical | ||||
| Gloves | To determine the | |||
| thickness of the | ||||
| gloves | Palm: 0.10mm, min | |||
| Finger: 0.10 mm, min | ||||
| Cuff: 0.10mm, min | pass | |||
| Physical Properties | ASTM D3577- | |||
| 09(Reapproved 2015) | ||||
| Standard Specification | ||||
| for Rubber Surgical | ||||
| Gloves | To Determine the | |||
| physical properties | ||||
| Tensile strength | Before Ageing | |||
| Tensile Strength 24Mpa | ||||
| Minimum for all sizes | ||||
| After Ageing | ||||
| Tensile Strength 18Mpa | ||||
| Minimum for all sizes | pass | |||
| ASTM D3577- | ||||
| 09(Reapproved 2015) | ||||
| Standard Specification | ||||
| for Rubber Surgical | ||||
| Gloves | To Determine the | |||
| physical properties | ||||
| Ultimate Elongation | Before Ageing | |||
| Ultimate Elongation | ||||
| 750% Min for all sizes | ||||
| After Ageing | ||||
| Ultimate Elongation | ||||
| 560% Min for all sizes | pass | |||
| ASTM D3577- | ||||
| 09(Reapproved 2015) | ||||
| Standard Specification | ||||
| for Rubber Surgical | ||||
| Gloves | To Determine the | |||
| physical properties | ||||
| stress at 500 % | 5.5 Mpa, Max | pass | ||
| Watertight test | ASTM D5151-19 | |||
| Standard Test Method | ||||
| for Detection of | ||||
| Holes in Medical | ||||
| Gloves | To determine the | |||
| water tightness of the | ||||
| test gloves | AQL 1.5 | pass | ||
| Residual powder | ASTM D6124-06 | |||
| (Reapproved 2017) | ||||
| Standard Test Method | ||||
| for Residual Powder | ||||
| on Medical Gloves | To determine the | |||
| residual powder in | ||||
| the gloves | 2 mg per glove or less | pass | ||
| Protein content | ASTM D5712 - 15, | |||
| Standard Test Method | ||||
| for Analysis of | ||||
| Aqueous Extractable | ||||
| Protein in Natural | ||||
| Rubber. | To determine the | |||
| extractable protein in | ||||
| the gloves. | 50 µg/ dm² Max for all | |||
| sizes | pass | |||
| Skin Sensitization | ISO 10993-10 | |||
| Biological Evaluation | ||||
| of Medical Devices | ||||
| Test for Irritation and | ||||
| Skin Sensitization. | ||||
| Test done for irritation | The test was designed | |||
| to evaluate the | ||||
| potential of a test | ||||
| article to cause skin | ||||
| sensitization. | Under the conditions of | |||
| the study, not a | ||||
| sensitizer | pass | |||
| Irritation | ISO 10993-10 | |||
| Biological Evaluation | ||||
| of Medical Devices | ||||
| Test for Irritation and | ||||
| Skin Sensitization. | ||||
| Test done for irritation | To evaluate the | |||
| potential skin | ||||
| irritation caused by | ||||
| test article contact | ||||
| with the skin surface | ||||
| of rabbits. | Under the condition of | |||
| study, not an irritant | pass | |||
| Acute Systemic | ||||
| toxicity | ISO 10993-11:2017 | |||
| biological evaluation of | ||||
| medical devices - part | ||||
| 11, tests for systemic | ||||
| toxicity | The test article was | |||
| evaluated to | ||||
| determine whether | ||||
| leachable extracted | ||||
| from the test article | ||||
| would cause acute | ||||
| systemic toxicity | ||||
| following injection | ||||
| into mice. | Under the conditions of | |||
| study, the device extracts do | ||||
| not pose an acute systemic | ||||
| toxicity concern | pass | |||
| Material mediated | ||||
| pyrogenicity | Japanese Pharmacopeia | |||
| Rabbit Pyrogen Test | The test article was | |||
| evaluated to determine | ||||
| the risk of febrile | ||||
| reaction in rabbits | ||||
| following intravenous | ||||
| injection. | Under the conditions of the | |||
| study, non- pyrogenic | pass | |||
| Hemolysis test | ANSI/AAMI/ISO | |||
| 10993-4:2017 | The test article was | |||
| assessed to determine | ||||
| whether the test article | ||||
| would cause hemolysis | ||||
| in vitro by direct contact | ||||
| method. | Under the conditions of the | |||
| study, non-hemolytic | pass | |||
| Bacterial Endotoxin | USP 43 | |||
| Bacterial Endotoxin | ||||
| Test | Bacterial Endotoxin | |||
| Test |