(66 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and material composition of surgical gloves, with no mention of AI or ML.
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
Explanation: The device description clearly states that these are surgical gloves, intended to protect a surgical wound from contamination by being worn on the hands of operating room personnel. This function is protective and preventative, not diagnostic.
No
The device is a physical product (surgical gloves) and the description focuses entirely on material properties, physical dimensions, and sterilization methods, with no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn on the hands of operating room personnel to protect a surgical wound from contamination." This is a barrier function for protection, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical characteristics and materials of surgical gloves. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies and Key Metrics: The performance studies and key metrics listed (tensile strength, elongation, freedom from holes, etc.) are all related to the physical integrity and barrier properties of the gloves, not to diagnostic accuracy or performance.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Surgical gloves do not fit this definition.
N/A
Intended Use / Indications for Use
The Medispo Rubber/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 devices, surgical gloves, are sterile and disposable devices. There are two types of surgical gloves according to the raw materials in this submission:
- Type 1-Natural rubber surgical gloves .
- Type 2-Synthetic polyisoprene surgical gloves .
The proposed devices are powder-free gloves with creamy white in color. There are seven sizes (6", 6.5", 7", 7.5", 8", 8.5", 9") available for the gloves whichever are smooth- or texture-surfaced, with or without a rolled rim at the cuff edge.
The gloves are sterilized by ionizing irradiation. The shelf-life is three (3) years.
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)
Non-clinical performance tests were conducted in accordance with relevant standards to verify that the proposed device met all design specifications. The performance test of the subject devices were performed on the final finished device. The test results show the subject devices meet the requirements of ASTM D3577-19.
Key results:
- Palm width: Passed requirements of ASTM D3767-03(2020)
- Length: Passed requirements of ASTM D3767-03(2020)
- Thickness: Passed requirements of ASTM D3767-03(2020)
- Freedom from holes: Passed requirements of ASTM D5151-19
- Physical Properties (before aging) - Tensile Strength and Ultimate Elongation: Passed requirements of ASTM D412-16
- Physical Properties (after aging) - Tensile Strength and Ultimate Elongation: Passed requirements of ASTM D412-16
- Powder residual: Passed requirements of ASTM D6124-06(2017)
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).
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Image /page/0/Picture/2 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 1, 2021
Guilin HBM Health Protections, Inc. % Shelley Li Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, 200071 China
Re: K203483
Trade/Device Name: Medispo Rubber Surgical Gloves, Medispo 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: November 19, 2020 Received: November 27, 2020
Dear Shelley Li:
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 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,
For: Elizabeth F. Claverie-Williams, MS 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) K203483
Device Name
-
Medispo Rubber Surgical Gloves
-
Medispo Polyisoprene Surgical Gloves
Indications for Use (Describe)
The Medispo Rubber/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: K203483
l. Submitter
Guilin HBM Health Protections, Inc. No.1-2, Shuijing East Road, Economic and Technological Development Area, Guilin, China
Contact person: Pu Lei Position: QC Manager Tel.: +86-13707738532 E-mail: pulei@hbmchina.com
Preparation date: Jan. 11, 2021
II. Proposed Device
| Device Trade Name | 1) Medispo Rubber Surgical Gloves
2) Medispo Polyisoprene Surgical Gloves |
|--------------------|------------------------------------------------------------------------------|
| Common name: | Surgeon's gloves |
| Regulation Number: | 21 CFR 878.4460 |
| Regulatory Class: | Class I |
| Product code: | KGO |
| Review Panel | General Hospital |
III. Predicate Devices
| a. 510(k) Number: | K171047 |
|---|---|
| Trade name: | Sterile Polyisoprene Powder Free Surgical Gloves |
| Common name: | Surgeon's Gloves |
| Classification: | Class I |
| Product Code: | KGO |
| Manufacturer | Better Care Plastic Technology Co., Ltd. |
| b. 510(k) Number: | K192328 |
| Trade name: | JR Medic Latex Surgeon's Gloves Sterile Powder Free |
| Common name: | Surgeon's Gloves |
| Classification: | Class I |
| Product Code: | KGO |
| Manufacturer | JR Engineering & Medical Technologies (M) SDN.BHD. |
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IV. Device description
The proposed devices, surgical gloves, are sterile and disposable devices. There are two types of surgical gloves according to the raw materials in this submission:
- Type 1-Natural rubber surgical gloves .
- Type 2-Synthetic polyisoprene surgical gloves .
The proposed devices are powder-free gloves with creamy white in color. There are seven sizes (6", 6.5", 7", 7.5", 8", 8.5", 9") available for the gloves whichever are smooth- or texture-surfaced, with or without a rolled rim at the cuff edge.
The gloves are sterilized by ionizing irradiation. The shelf-life is three (3) years.
V. Indication for use
The 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.
| Item | Proposed device
(K203483) | Predicate device
(K192328) | Discussion |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Medispo Rubber Surgical
Gloves | JR Medic Latex Surgeon's
Gloves Sterile Powder Free | - |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification | Class I | Class I | Same |
| Gloves
classification | Type I, Surgeon's gloves | Type I, Surgeon's gloves | Same |
| Powder free | Yes | Yes | Same |
| Indication for
use | The 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. | A latex surgeon's glove is a
device made of natural
rubber intended to be worn
by operating room personnel
to protect a surgical wound
from contamination. | Same |
| Main Material | Natural rubber | Natural rubber | Same |
| Color | Creamy white | Creamy white | Same |
| Palm width | 6.0 (76mm±5mm)
6.5 (83mm±5mm)
7.0 (89mm±5mm) | 6.0 (78mm)
6.5 (85mm)
7.0 (88mm) | Similar |
| | | | |
| | 7.5 (95mm±5mm) | 7.5 (97mm) | |
| | 8.0 (102mm±6mm) | 8.0 (103mm) | |
| | 8.5 (108 mm±6mm) | 8.5 (110mm) | |
| | 9 (114mm±6mm) | 9(116mm) | |
| Length | 6.0 (265mm min)
6.5 (265mm min)
7.0 (270mm min)
7.5 (270mm min)
8.0 (270mm min)
8.5 (280mm min)
9 (280mm min) | 300 mm | Different |
| Thickness | Cuff: min 0.10mm
Palm: min 0.13mm
Finger tip: min 0.13mm | Cuff: 0.11mm
Palm: 0.18mm
Finger tip: 0.21mm | Similar |
| Freedom from
holes | Meets requirements of the
ASTM D3577-19 | Meets requirements of the
ASTM D3577-09(2015) | Similar |
| Physical
Properties
(before aging) | Meets requirements of the
ASTM D3577-19 | Meets requirements of the
ASTM D3577-09(2015) | Similar |
| Physical
Properties
(after aging) | Meets requirements of the
ASTM D3577-19 | Meets requirements of the
ASTM D3577-09(2015) | Similar |
| Powder
residual | ≤2.0 mg/glove | ≤2.0 mg/glove | Same |
| Special label
claim | No protein labeling statement | Protein content label claim of
50µg/dm² or less | Different |
| Sterility | Sterile | Sterile | Same |
| Sterilization
method | Radiation | Radiation | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | Conform to the requirements
of ISO 10993 series
standards | Conform to the requirements
of ISO 10993 series
standards | Same |
| Table 2 Comparison of Polyisoprene Surgical Gloves | | | |
| Item | Proposed device
(K203483) | Predicate device
(K171047) | Discussion |
| Product name | Medispo Polyisoprene
Surgical Gloves | Sterile Polyisoprene Powder
Free Surgical Gloves | - |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification | Class I | Class I | Same |
| Gloves
classification | Type II, Surgeon's gloves | Type II, Surgeon's gloves | Same |
| Powder free | Yes | Yes | Same |
| Indication for
use | The 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. | A latex surgeon's glove is a
device made of natural
rubber intended to be worn
by operating room personnel
to protect a surgical wound
from contamination. | Same |
| Main Material | Synthetic Polyisoprene | Synthetic Polyisoprene | Same |
| Color | Creamy white | Creamy white | Same |
| Palm width | 6.0 (76mm±5mm)
6.5 (83mm±5mm)
7.0 (89mm±5mm)
7.5 (95mm±5mm)
8.0 (102mm±6mm)
8.5 (108 mm±6mm
9 (114mm±6mm) | 5.5 (70mm)
6.0 (76mm)
6.5 (83mm)
7.0 (89mm)
7.5 (95mm)
8.0 (102mm)
8.5 (108mm)
9 (114mm) | Similar |
| Length | 6.0 (265mm min)
6.5 (265mm min)
7.0 (270mm min)
7.5 (270mm min)
8.0 (270mm min)
8.5 (280mm min)
9 (280mm min) | Minimum 265
Average 305 mm | Similar |
| Thickness | Cuff: 0.10mm min
Palm: 0.13mm min
Finger tip: 0.13mm min | Cuff: 0.10mm min
Palm: 0.10mm min
Finger tip : 0.10mm min | Similar |
| Freedom from | Meets requirements of the | Meets requirements of the | Similar |
| | | | |
| holes | ASTM D3577-19 | ASTM D3577-09(2015) | |
| Physical
Properties
(before aging) | Meets requirements of the
ASTM D3577-19 | Meets requirements of the
ASTM D3577-09(2015) | Similar |
| Physical
Properties
(after aging) | Meets requirements of the
ASTM D3577-19 | Meets requirements of the
ASTM D3577-09(2015) | Similar |
| Powder
residual | ≤2.0 mg/glove | ≤2.0 mg/glove | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilization
method | Radiation | Radiation | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | Conform to the requirements
of ISO 10993 series
standards | Conform to the requirements
of ISO 10993 series
standards | Same |
VI. Comparison of technological characteristics with the predicate devices Table 1 Comparison of Natural Rubber Surgical Gloves
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6
7
The performance test of the subject devices were performed on the final finished device. The test results show the subject devices meet the requirements of ASTM D3577-19.
VII. Summary of Non-Clinical Testing
Non-clinical performance tests were conducted in accordance with relevant standards to verify that the proposed device met all design specifications.
| Items | Methodology /
Standard | Acceptance Criteria | Results |
|------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------|---------|
| Palm width | ASTM D3767-03(2020) | 6.0 (76mm±5mm)
6.5 (83mm±5mm)
7.0 (89mm±5mm)
7.5 (95mm±5mm)
8.0 (102mm±6mm)
8.5 (108 mm±6mm)
9 (114mm±6mm) | Pass |
8
| Length | ASTM D3767-03(2020) | 6.0 (265mm min)
6.5 (265mm min)
7.0 (270mm min)
7.5 (270mm min)
8.0 (270mm min)
8.5 (280mm min)
9 (280mm min) | Pass |
|---------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------|------|
| Thickness | ASTM D3767-03(2020) | Cuff: min 0.10mm
Palm: min 0.13mm
Finger tip: min 0.13mm | Pass |
| Freedom
from holes | ASTM D5151-19 | Freedom free hole AQL
1.5 | Pass |
| Physical Properties
(before aging) | | | |
| Tensile
Strength | ASTM D412-16 | ≥24 MPa | Pass |
| Ultimate
Elongation | ASTM D412-16 | ≥750% | Pass |
| Physical Properties
(after aging) | | | |
| Tensile
Strength | ASTM D412-16 | ≥18 MPa | Pass |
| Ultimate
Elongation | ASTM D412-16 | ≥560% | Pass |
| Powder
residual | ASTM D6124-06(2017) | 2mg per glove | Pass |
The relevant standards used in the submission are listed as below:
- ASTM D3577-19, Standard Specification for Rubber Surgical Gloves .
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions .
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical . Gloves
- . ASTM D5712-15, Standard Test Method for The Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air . Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and . Thermoplastic Elastomers-Tension
9
- USP 42/NF37 Pyrogen Test ●
- USP 36_NF 31Sterility Test ●
- ISO 11137-1:2006, Sterilization of health care products Radiation Part 1: ● Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013, Sterilization of health care products -- Radiation -- Part 2: . Establishing the sterilization dose
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For . In Vitro Cytotoxicity
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biocompatibility Evaluation of Medical Device Part 11: Tests . for systemic toxicity
- ISO 10993-4:2017. Biological evaluation of medical devices-Part 4: Selection of . tests for interactions with blood
- ASTM F756-17 Standard Practice for assessments of hemolytic properties of ● material
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.