(127 days)
Not Found
No
The device description and performance studies focus on material properties, sterilization, and physical characteristics of surgical gloves, with no mention of AI or ML.
No
The device, Single-Use Latex Sterile Surgical Gloves, is intended to protect a surgical wound from contamination, which is a preventative rather than a therapeutic function.
No
Explanation: The device is described as "Single-Use Latex Sterile Surgical Gloves" intended "to be worn by operating room personnel to protect a surgical wound from contamination." Its function is protective and not for diagnosing any medical condition or disease.
No
The device description clearly states it is a physical product made of natural rubber latex (surgical gloves) and details its physical characteristics and testing. There is no mention of software as the primary or sole component.
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 physical barrier function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description focuses on the physical properties and manufacturing standards of a surgical glove. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or analytical methods
The device is clearly described as a surgical glove, which is a medical device used for protection and barrier purposes in a surgical setting.
N/A
Intended Use / Indications for Use
The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The proposed device, Single-Use Latex Sterile 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-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9.
The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D3577-19: Standard Specification for Rubber Surgical Gloves.
- 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 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
- ASTM D7160-05 Standard Practice for Determination of Expiration Dating for medical Gloves
- 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
- ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 5: Tests For systemic toxicity
- ISO 11137-1-2006/ (R) 2010 validation of sterilization process
- ISO 11137-2:2013, sterilization of health care products radiation part 2: Establishing the sterilization dose
Key results:
- Physical Dimension (ASTM D3577-19): Meets the requirement.
- Determination of Physical Properties (ASTM D3577-19): Meets the requirement.
- Water Leak Test for Detection of Holes (ASTM D5151-19): Meets the requirement AQL 1.5.
- Residual Powder Content Test (ASTM D6124-06(2017)): Meets the requirement.
- Protein Content (ASTM D5712-15): Meets the requirement.
- Skin Sensitization (ISO 10993-10:2010): Meets the requirement.
- Skin irritation (ISO 10993-10:2010): Meets the requirement.
- Systemic toxicity (ISO 10993-11:2017): Meets the requirement.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 22, 2023
Fitone Latex Products Co., Ltd. Guangdong % Kvra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555. Jingan District Shanghai, 200072 China
Re: K231446
Trade/Device Name: Single-Use Latex Sterile Surgical Gloves (SG100) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: September 11, 2023 Received: September 11, 2023
Dear Kyra Kang:
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.
1
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) 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 medical devices and radiation-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 -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B2: Personal Protective Equipment, Reprocessing & Disinfection Devices Team 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Single-Use Latex Sterile Surgical Gloves (SG100)
Indications for Use (Describe)
The Single-Use Latex Sterile Surgical Gloves are 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K231446
l. Submitter
Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China
Contact person: Christine Ou Position: Manager Tel.: 0759-7905808 E-mail: market-intl@fitonelatex.com
Preparation date: Sept. 19, 2023
Submission Correspondent
Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com
US Agent
Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476
II. Proposed Device
| Device | Trade Name: Single-Use Latex Sterile Surgical Gloves |
|---|---|
| Model: | SG100 |
| Common name: | Surgeon's Gloves |
| Regulation Number: | 21 CFR 878.4460 |
| Regulatory Class: | Class I |
| Product code: | KGO |
| Review Panel: | General Hospital |
4
III. Predicate Device
| 510(k) Number: K212848 | |
|---|---|
| Trade name: | Sterile Latex Surgical Gloves Powder Free |
| Common name: | Surgeon's Gloves Classification: Class I |
| Product Code: | KGO |
| Manufacturer | Pentavest Holdings Sdn Bhd |
IV. Device Description
- The proposed device, Single-Use Latex Sterile 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-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9.
The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.
V. Indication for use
The Single-Use Latex Sterile Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
5
| Characteristic | Proposed device
K231446 | Predicate device
K212848 | Discussion |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Single-Use Latex
Sterile Surgical
Gloves | Sterile Latex Surgical
Gloves Powder Free | Similar |
| Indications For
Use | The Single-Use Latex
Sterile Surgical Glove
is a device made of
natural rubber
intended to be worn
by operating room
personnel to protect a
surgical wound from
contamination. | A Sterile Latex Surgical
Gloves Powder Free is a
device made of natural
rubber intended to be worn
by operating room personnel
to protect a surgical wound
from contamination. | Similar |
| Product Code | KGO | KGO | Same |
| Regulation
Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Powdered or
Powder free | Powdered free | Powdered free | Same |
| Classification as
per ASTM
D3577- 2019 | Type I - gloves
compounded primarily
from natural rubber
latex | Type I - gloves
compounded primarily from
natural rubber latex | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Shelf Life | 3 Years | 3 Years | Same |
| Sterilization | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Same |
| Single use | Yes | Yes | Same |
| Label and
Labeling | Meet FDA's
Requirement | Meet FDA's Requirement | Same |
| Protein Content | 141µg/dm² | 50µg/dm² | Similar |
VI. Comparison of Technological Characteristics with the Predicate Device
Table
6
| Characteristics | Acceptance criteria of the
standard | | Remarks |
|-----------------------------------------------------|------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Subject device
K231446 | Predicate device
K212848 | |
| Dimensions Length:-
Min 265 mm | 281 mm | 380 mm | Similar
Meets ASTM D3577-2019,
Standard Specification for
Rubber Surgical Gloves |
| Size | | | |
| 6.0 (76+/-6mm) | 76mm | 74mm | Similar |
| 6.5 (83+/-6mm) | 84mm | 86mm | Meets ASTM D3577-2019,
Standard Specification for
Rubber
Surgical Gloves |
| 7.0 (89+/-6mm) | 90mm | 92mm | |
| 7.5 (95+/-6mm) | 96mm | 98mm | |
| 8.0 (102+/6mm) | 102mm | 105mm | |
| 8.5 (108+/6mm) | 109mm | 110mm | |
| 9.0 (114+/6mm) | 115mm | 116mm | |
| Cuff, Palm, Finger Tip
Min
0.10 mm | Cuff- 0.16mm
Palm-0.18mm
Finger Tip-
0.22mm | Cuff- 0.12mm
Palm-0.16mm
Finger Tip-
0.21mm | |
| Tensile Strength
24Mpa minimum
Before Aging | 37Mpa | 28.55Mpa | Similar
Meets ASTM D3577-2019,
Standard Specification for |
| Ultimate Elongation
750% minimum
Before Aging | 814% | 870% | Rubber Surgical Gloves |
| Stress at 500%
5.5 MPa Max
Before Aging | 3.5Mpa | 5.1Mpa | |
| Tensile Strength 18Mpa
minimum
After Aging | 32.49Mpa | 23.48Mpa | Similar
Meets ASTM D3577-2019,
Standard Specification for
Rubber
Surgical Gloves |
| Ultimate Elongation
560% minimum After
Aging | 760% | 731% | |
7
| Characteristics | Acceptance criteria of the
standard | | Remarks |
|---------------------------------------------------------------------------|----------------------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject device
K231446 | Predicate
device
K212848 | |
| Freedom from
Holes
AQL 1.5 | AQL 1.5 | AQL 1.0 | Similar
Meets ASTM D3577-2019 and
ASTM D5151-2019,
Standard Test Method for
Detection of Holes in Medical
Gloves |
| Powder residue for
powder free glove
Powder content Pyrogen Test | Non pyrogenic | No data available | ----- |
| Acute Systemic
Toxicity | ISO 10993-11:2017(E)
,Biological Evaluation
of Medical Devices -
Part 11, Tests for
Systemic Toxicity | Under the
conditions of
study the
device extracts
do not pose an
acute systemic
toxicity
concern | Under the
conditions of study
the
device extracts do
not pose an acute
systemic toxicity
concern | Same |
| Bacterial
Endotoxin | USP 42 |