(336 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of surgical gloves, with no mention of AI or ML.
No.
The device's intended use is to protect a surgical wound from contamination, not to treat or cure a disease or medical condition, which is the primary characteristic of a therapeutic device.
No
The device description clearly states its purpose is to protect a surgical wound from contamination, explicitly stating it's a glove for operating room personnel. No mention of diagnosis is made.
No
The device description clearly states the device is a physical product made of natural rubber latex (surgical gloves) and describes physical and biological testing, not software characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "be worn by operating room personnel to protect a surgical wound from contamination." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties, material, sterilization, and sizing of a surgical glove. It does not mention any components or functions related to analyzing samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or markers.
- Performance Studies: The performance studies listed are related to the physical integrity, biological safety, and sterilization of the glove, not diagnostic accuracy.
In summary, the device is a physical barrier intended for protection during surgery, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KGO
Device Description
The proposed device, Disposable Sterilized Latex Surgical Gloves 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, 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 proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The disposable sterilized latex surgical glove shelf life is 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The non-clinical testing included physical properties (length, width, thickness, tensile strength, ultimate elongation), watertightness, residual powder, protein content, biocompatibility (skin sensitization, irritation, systemic toxicity, pyrogen, bacterial endotoxin), EO residue, and ECH residue tests. All tests met the specified criteria based on relevant ASTM and ISO standards.
Key Metrics
Watertight test: AQL 1.5, Criteria: ≤8 pieces (Pass)
Residual powder: 2 mg per glove or less (Pass)
Protein content: 200 microgram/dm squared Max for all sizes (Pass)
EO Residue: ≤10ug/cm² (Pass)
ECH Residue: ≤5mg/cm² (Pass)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
May 25, 2022
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd % Alice Huang RA Manager Shanghai Mind-Link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China
Re: K211953
Trade/Device Name: Disposable Sterilized 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: April 15, 2022 Received: April 25, 2022
Dear Alice Huang:
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
1
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) 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 (QS) 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,
Bifeng Qian, M.D., Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211953
Device Name Disposable Sterilized Latex Surgical Gloves
Indications for Use (Describe)
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.
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
K211953
I. SUBMITTER:
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. No. 316 National road, Xinju, Changshan Town, Jinxian County, Nanchang City, 331724, Jiangxi Province, China. Contact Person: Jenny Huang
TITLE: International Trade Supervisor
TEL. : +86 17702094798
Email: sales@jxkmjt.com
Submission Correspondent: Alice Huang Email: alice.huang(@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai
Summary prepared: 05/23/2022
II. DEVICE 510(k) Number: K211953 Name of Device: Disposable Sterilized Latex Surgical Gloves Regulation Number: 21 CFR878.4460 Common Name: Surgeon's Gloves Classification Name: Non-powdered surgeon's glove Regulatory Class: I Product Code: KGO
III. PREDICATE DEVICE
510(k) Number: K171550 Product Name: Sterile Latex Surgical Gloves, Powder Free Manufacture: Sanrea Healthcare Pvt Ltd
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IV. DEVICE DESCRIPTION
The proposed device, Disposable Sterilized Latex Surgical Gloves 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, 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 proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 106. The disposable sterilized latex surgical glove shelf life is 3 years.
V. INDICATIONS FOR USE
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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Disposable Sterilized Latex Surgical Gloves are compared with the predicate device (Sterile Latex Surgical Gloves, Powder Free, K171550). The results are shown below in the Technological Characteristics Comparison Table:
| DEVICE | Subject Device | Primary Predicate Device
(K171550) | Comparison |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Indications For Use | 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. | The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber, intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. | Same |
| Intended Use | 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. | Intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. | Same |
| Classification
Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | I | I | Same |
| Powdered or
Powdered free | Powdered free | Powdered free | Same |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| Dimensions | 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 6: 76 ±6 mm
Size 6.5: 83 ± 6 mm
Size 7: 89 ± 6 mm
Size 7.5: 95 ± 6 mm
Size 8: 102 ± 6 mm
Size 8.5: 108 ± 6 mm
Palm Thickness: 0.10mm, min
Finger Thickness: 0.10mm, min
Cuff Thickness: 0.10mm, min | size 7.5 :
Length : 300mm
size 7.5 :
Width : 95mm
Palm Thickness: 0.19mm
Finger Thickness: 0.22mm
Cuff Thickness: 0.14mm | Similar
Meeting
requirement
of ASTM
D 3577 |
| Biocompatibility | Under the conditions of the study, not a sensitizer.
Under the conditions of the study, not an irritant.
Under the conditions of the study, no evidence of acute systemic toxicity. | Non-sensitizing
Non-irritating | Similar |
| Tensile strength | Before Aging 24MPa, min
After Aging 18MPa, min | Before Aging 31.22MPa
After Aging 24.43MPa | Similar
Meeting |
| Ultimate
Elongation | Before Aging 750%, min
After Aging 560%,min | Before Aging 843.09%
After Aging 762.28% | requirement
of ASTM
D 3577 |
| Freedom from | Meets ASTM D5151-06(2015) | Meets ASTM D 5151 -06 | Same |
| Holes | AQL 1.5 | (2011) | |
| Protein Content | Meets ASTM D5712-2015 | Meets ASTM D5712 | Same |
| Powdered residue | Meets ASTM D6124-06(Reapproved 2017) | Meets ASTM D 6124-06(2011) | Same |
| Sterility | EO | EO | Same |
| EtO and ECH residuals | Meets ISO 10993-7:2008 | Meets ISO 10993-7:2008 | Same |
| Shelf life | 3 Years | 3 Years | Same |
| Single Use | YES | YES | Same |
| Label and labeling | Meet FDA's Requirement | Meet FDA's Requirement | Same |
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VII. SUMMARY OF NON-CLINICAL TESTING
The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below:
- ASTM D5151-06(Reapproved 2015) 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 D3577-09 (Reapproved 2015) 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 : 2009 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
- USP 43-NF 38 Pyrogen Test
- USP 43 Bacterial Endotoxin Test
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
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- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ASTM D7160 Standard Practice for Determination of Expiration Dating for medical Gloves
| Test
| Method | Standard | Test Purpose | Criteria | Result |
|---|---|---|---|---|
| Dimension | ASTM D3577-09(Reapproved |
- 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 6: 76 ±6 mm
Size 6.5: 83 ± 6 mm
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 - Standard Specification for
Rubber Surgical Gloves | To determine the
thickness of the gloves | Palm: 0.10mm, min
Finger: 0.10mm, min
Cuff: 0.10mm, min | Pass |
| Physical
Properties | ASTM D3577-09(Reapproved - Standard Specification for
Rubber Surgical Gloves | To Determine the
physical properties
Tensile strength | Before Ageing
Tensile Strength
24Mpa Minimal for all
sizes
After Ageing
Tensile Strength
18Mpa Minimal for all
sizes | Pass |
| | ASTM D3577-09(Reapproved - 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 |
| Watertight
test | ASTM D5151-19 Standard Test
Method for Detection of Holes in
Medical Gloves | To determine the
watertightness of the test
gloves | Sample size: 200 pcs
Inspection level : GI
AQL 1.5
Criteria:≤8 pieces | Pass |
| Residual
powder | ASTM D6124-06 (Reapproved - Standard Test Method for | To determine the
residual powder in the | 2 mg per glove or less | Pass |
| | Residual Powder on Medical
Gloves | gloves | | |
| 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. | $200 \mu g/dm^2$ 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 |
| 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 leachables
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 a
systemic toxicity
concern | Pass |
| Pyrogen | USP 43-NF 38 Pyrogen Test | The test article was
evaluated for the risks of
febrile reaction in the
rabbit to the
administration by
injection. | Under the condition of
study not a pyrogen | Pass |
| Bacterial
Endotoxin | USP 43 Bacterial
EndotoxinTest | Bacterial EndotoxinTest |