(187 days)
No
The device description and performance studies focus on material properties and standard testing for surgical gloves, with no mention of AI or ML.
No
The device is described as surgical gloves intended to protect a surgical wound from contamination, which is a barrier function, not a therapeutic action to treat or cure a disease or condition.
No
Explanation: The device, Polyisoprene Surgical Gloves, is intended to protect a surgical wound from contamination by being worn on the hands of operating room personnel. Its function is protective, not diagnostic.
No
The device is a physical product (surgical gloves) made of polyisoprene, not software. The description focuses on material properties and physical performance standards.
Based on the provided information, 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 on the hands of operating room personnel. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a surgical glove made of polyisoprene. This is a physical product, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.
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)
No clinical study is included in this submission.
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
Results for biological evaluation tests:
- Skin Sensitization Test: All grades are 0. All animals were survived, and no abnormal signs were observed during the study.
- Skin Irritation Test: The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
- In Vitro Cytotoxicity: Viab.% of 100% test article extract is 6.1%. It means the proposed device have potential toxicity to L-929 in the MTT method.
- Systemic Toxicity: There was no evidence of systemic toxicity from the extract.
Results for physical and chemical tests: - EO/ECH residual testing: EO residue:
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2023
Puyang Linshi Medical Supplies Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K230304
Trade/Device Name: Polyisoprene 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 8, 2023 Received: July 11, 2023
Dear Boyle Wang:
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 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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230304
Device Name Polyisoprene Surgical Gloves
Indications for Use (Describe)
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of 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 (K230304)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Puyang Linshi Medical Supplies Co., Ltd. Address: East of Panjin Road and North of Fumin Road in Puyang County, Puyang City, Henan Province 457001, China. Phone Number: +86-19839327898 Contact: Catherine Liu Date of Preparation: 08.01.2023
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Polyisoprene Surgical Gloves Common name: Surgeon's Gloves Classification name: Surgeon's Gloves Model(s): 6.5, 7, 7.5, 8
3.0 Classification
Production code: KGO Regulation number: 21CFR878.4460 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Better Care Plastic Technology Co., Ltd. Manufacturer: Sterile Polyisoprene Powder Free Surgical Gloves Device: 510(k) number: K171047
5.0 Indications for use
4
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
6.0 Device description
The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.
7.0 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| 510(k) number | K230304 | K171047 | |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21CFR878.4460 | 21CFR878.4460 | Same |
| Class | I | I | Same |
| Indications | |||
| for Use | The Polyisoprene Surgical Gloves are sterile and single use device intended to | ||
| be worn on the hands of | |||
| operating room personnel to | |||
| protect a surgical wound | |||
| from contamination. | This surgeon's glove is a sterile and single use device intended to | ||
| be worn on the hands of | |||
| operating room personnel to | |||
| protect a surgical wound from | |||
| contamination. | Same | ||
| Prescription or Over | |||
| The Counter Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Materials | Synthetic polyisoprene rubber | Synthetic polyisoprene rubber | Same |
| Design | Single use | ||
| Sterile | |||
| Powder-free | |||
| Hand Specific | |||
| Beaded cuff | Single use | ||
| Sterile | |||
| Powder-free | |||
| Hand Specific | |||
| Beaded cuff | Same | ||
| Color | White | Clear | Difference 1 |
| Dimensions and | |||
| physical properties | Meets ASTM D3577- 2019 | Meets ASTM D3577-09 (2015) | Difference 2 |
| Sterilization | |||
| method | EO Sterilization | Radiation | Difference 3 |
| Sterility Assurance | 10-6 SAI | 10-6 SAI | Same |
Table1-General Comparison
5
| Level (SAL) | |||
|---|---|---|---|
| Freedom from | |||
| holes | Meets ASTM D3577- 2019 Clause | ||
| 8.3 (ASTM D5151-19) | |||
| Inspection level/AQL: GI/AQL 1.5 | Meets ASTM D3577- 09(2015) | ||
| Inspection level/AQL: GI/AQL 1.5 | Difference 2 | ||
| Powder-Free | Meets ASTM D 6124-06 The | ||
| averaged residual powder content | |||
| for the glove during process | |||
| validation is 0.1mg per glove | Meets ASTM D 6124-06 The | ||
| averaged residual powder | |||
| content for the glove | |||
| during process validation is | |||
| 0.16mg per glove | Similar | ||
| Primary Skin | |||
| Irritation | |||
| ISO 10993- 10:2010 | Under the conditions of the | ||
| study (per ISO 10993-23), the | |||
| device is not an irritant | Under the conditions of the | ||
| study (per ISO 10993-10), the | |||
| device is not an irritant | Difference 4 | ||
| Dermal | |||
| Sensitization - | |||
| ISO 10993-10:2010 | Under the conditions of the | ||
| study (per ISO 10993-10), not | |||
| a sensitizer | Under the conditions of the | ||
| study (per ISO 10993-10), not | |||
| a sensitizer | Same | ||
| Acute Systemic | |||
| Toxicity - ISO | |||
| 10993-11: 2006 | Under the conditions of the study, | ||
| there was no mortality or evidence | |||
| of Acute systemic | |||
| toxicity | Under the conditions of the study, | ||
| there was no mortality or | |||
| evidence of Acute systemic | |||
| toxicity | Same | ||
| Shelf Life | 2 years | 3 years | Difference 5 |
Analysis:
Difference 1: The colors of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D3577-19, so the differences do not raise any new safety or performance questions.
Difference 2: The proposed device and the predicate device meet different requirements ASTM D3577-19 and ASTM D3577-09 as the ASTM D3577-19 is the only Consensus Standard for Rubber Surgical Gloves Recognized by FDA, but the differences do not raise any new safety or performance questions.
Difference 3: The proposed device and the predicate device sterilized by different methods EO Sterilization and Radiation, but the EO validation of proposed device was implemented based on ISO 11135:2014, including sterilizer installation, OQ, PPQ and MPQ of sterilization. And parameters in Sterilization Validation Report can prove these products being SAL of 10-6.
Difference 4: New standard ISO10993-23:2021 replaces the Skin Irritation test in ISO10993-10:2010. Difference 5: The shelf life of proposed device is verified by Product Performance Test Report after 2 Years Accelerated Aging.
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8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| No. | Name of the Test
Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010
Biological Evaluation Of
Medical Devices - Part
10: Tests For Skin
Sensitization. | This part of ISO
10993 assesses
possible contact
hazards released
from medical devices, | Skin Sensitization Test:
provided
grades less than 1,
otherwise sensitization. | All grades are 0.
All animals were survived, and no abnormal signs were observed during the study. |
| 2 | ISO 10993-23:2021
Biological evaluation of
medical devices - Part
23: Tests for irritation | which may produce
skin and mucosal
irritation, eye irritation
or skin sensitization. | Skin Irritation Test:
If the primary irritation
index is 0-0,4, the
response category is
Negligible.
0,5-1,9 means slight
2-4,9 means moderate
5-8 means severe | The primary irritation index is 0.
The response of the proposed device was categorized as negligible under the test condition |
| 3 | ISO 10993-5:2009
Biological Evaluation Of
Medical Devices - Part
5: Tests For In Vitro
Cytotoxicity | This part of ISO
10993 describes test
methods to assess
the in vitro cytotoxicity
of medical devices. | The viab.% of the 100%
extract of the test article
is the final result, and if
viability is reduced to
24 h