← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K222693
# Single-use medical latex examination gloves (LG100) (K222693)
_Fitone Latex Products Co., Ltd. Guangdong · LYY · Sep 24, 2022 · General Hospital · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K222693
## Device Facts
- **Applicant:** Fitone Latex Products Co., Ltd. Guangdong
- **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md)
- **Decision Date:** Sep 24, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital
## Indications for Use
The Single-use medical latex examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
## Device Story
Single-use medical latex examination gloves (LG100) are disposable, non-sterile natural rubber latex gloves. Used by clinicians in medical settings to provide a physical barrier between the examiner's hand and the patient, preventing cross-contamination. The device is worn on the hand or finger during examinations. Effectiveness is established through physical barrier testing, biocompatibility, and adherence to ASTM standards. Benefits include protection against contamination during routine medical procedures.
## Clinical Evidence
No clinical data. Bench testing only. Testing included physical dimensions, physical properties (tensile strength, elongation), water leak test (ASTM D5151-19), residual powder content (ASTM D6124-06), protein content (ASTM D5712-15), and biocompatibility (ISO 10993 series).
## Technological Characteristics
Material: Natural rubber latex. Form factor: Non-sterile, powder-free, five sizes (XS-XL). Standards: ASTM D3578-19 (physical properties/dimensions), ASTM D5151-19 (barrier), ASTM D6124-06 (powder), ASTM D5712-15 (protein). Biocompatibility: ISO 10993-1, 10, 11. Shelf life: 3 years.
## Regulatory Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
## Predicate Devices
- Examination gloves-Type A (Latex gloves) ([K214017](/device/K214017.md))
## Submission Summary (Full Text)
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September 24, 2022
Fitone Latex Products Co., Ltd. Guangdong % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room1308,Baohua International Plaza,West Guangzhong Road 555 Jingan District Shanghai. 200072 China
Re: K222693
Trade/Device Name: Single-use medical latex examination gloves (LG100) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 30, 2022 Received: September 6, 2022
Dear Stuart Situ:
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.
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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.
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
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## Indications for Use
Submission Number (if known)
K222693
Device Name
Single-use medical latex examination gloves (LG100)
Indications for Use (Describe)
The Single-use medical latex examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary - K222693
### I. 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: September 20, 2022
### Submission Correspondent
Ms. Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: stuart.situ@landlink-healthcare.com
### US Agent
Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476
### II. Proposed Device
| Device Trade Name: | Single-use medical latex examination gloves |
|--------------------|---------------------------------------------|
| Model: | LG100 |
| Common name: | Latex Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LYY |
| Review Panel: | General Hospital |
### III. Predicate Devices
| 510(k) Number: | K214017 |
|----------------|------------------------------------------|
| Trade name: | Examination gloves-Type A (Latex gloves) |
| Common name: | Latex Patient Examination Glove |
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| Classification: | Class I |
|-----------------|------------------------------------------------------------------|
| Product Code: | LYY |
| Manufacturer | Jiangxi Kemei Medical Apparatus & Instruments Group
Co., Ltd. |
## IV. Device description
The proposed device. The Single-use medical latex examination qloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.
### V. Indication for use
The Single-use medical latex examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Item | Proposed device
(K222693) | Predicate device
(K214017) | Discussion |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product
name | Single-use medical latex
examination gloves | Examination gloves-Type
A(Latex gloves) | - |
| Indications
For Use | The Single-use medical
latex examination gloves is a
disposable device intended
for medical purposes that is
worn on the examiner's hand
or finger to prevent
contamination between
patient and examiner. | The Examination gloves-
Type A (Latex gloves) is
a disposable device
intended for medical
purposes that is worn on
the examiner's hand or
finger to prevent
contamination between
patient and examiner. | Same |
| Product
Code | LYY | LYY | Same |
#### VI. Comparison of technological characteristics with the predicate devices Table 1 General Comparison of Single-use medical latex examination gloves
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| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
|------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------|
| Class | I | I | Same |
| Powdered or
Powdered free | Powdered free | Powdered free | Same |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| Color | No colour pigment added.
Natural White | No colour pigment added.
Natural White | Same |
| Dimensions | Length:
6(XS): 238-241 mm
61/2(S):240-245mm
71/2(M): 240-245mm
81/2(L):246-250mm
9(XL): 246-252mm | Length:
S: 240-244mm
M: 241-245mm
L: 242-245mm | Similar
Meeting
requirem
ent of
ASTM D
3578 |
| | Width:
6(XS): 74-76 mm
61/2 (S):80-84mm
71/2 (M): 94-97mm
81/2 (L): 105-108mm
9(XL): 114-120mm | Width:
S: 84-86mm
M: 96-98mm
L: 105-108mm | Similar
Meeting
requirem
ent of
ASTM D
3578 |
| | Palm Thickness: 0.11-
0.13mm
Finger Thickness: 0.13-
0.16mm | Palm Thickness: 0.11-
0.13mm
Finger Thickness: 0.13-
0.14mm | Similar
Meeting
requirem
ent of
ASTM D
3578 |
| Biocompatibility | Non-sensitizing
Non-irritating
Non-systemic toxicity | Non-sensitizing
Non-irritating
Non-systemic toxicity | Same |
| Tensile
strength | Before Aging $24.4$ MPa,
min
Stress at
500 %
Elongation | Before
Aging $20.6$ MPa,
min
Stress at
500 %
Elongation | Similar
Meeting
requirem
ent of
ASTM D |
| | | $4.2$ Mpa,
max | $5.1$ Mpa,
max |
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| | After Aging | 20.5 MPa, min | After Aging | 18.9MPa, min | 3578 |
|---------------------|--------------------------------------|---------------|--------------------------------------|--------------|----------|
| Ultimate Elongation | Before Aging | 650%, min | Before Aging | 683%, min | |
| | After Aging | 524%, min | After Aging | 623%, min | |
| Freedom from Holes | Meets ASTM D5151-19 AQL=2.5 | | Meets ASTM D5151-19 AQL=2.5 | | Same |
| Protein Content | Meets ASTM D5712-2015 | | Meets ASTM D5712-2015 | | Same |
| Powdered residue | Meets ASTM D6124-06(Reapproved 2017) | | Meets ASTM D6124-06(Reapproved 2017) | | Same |
| Sterility | Non-sterile | | Non-sterile | | Same |
| Shelf life | 3 Years | | 5 Years | | Similar¹ |
| Single Use | Yes | | Yes | | Same |
| Label and labeling | Meet FDA's Requirement | | Meet FDA's Requirement | | Same |
1 The Shelf life of proposed device and predicate device is different; However, the product performance after 3 years has been determined based on accelerated aging study. The results can demonstrate that the performance of proposed device meets the ASTM D3578 requirements after 3 years accelerated aging.
# VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- . 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 D3578-19 Standard Specification for Rubber Examination 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 .
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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
| Test Methodology | Purpose | Acceptance Criteria | Results |
|-------------------------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| ASTM D3578-19 | Physical Dimension | The actual measured
dimension of the
gloves shall be meet
the stated tolerance
specified in Table 2 of
the ASTM D3578-19
Width ± 10mm
Length XS-S 220 min
and M-XL 230 min
Thickness (finger and
Palm): 0.08 min | Meet the
requirement |
| ASTM D3578-19 | Determination of
Physical Properties | Before and after
accelerated aging, the
gloves shall conform
to the physical
requirements in the
Table 3 of ASTM
D3578-19
Before Aging:
Tensile Strength: 18
MPa min
Stress Elongation: 5.5
MPa max
Ultimate Elongation:
650% min
After Accelerated
Aging:
Tensile Strength: 14
MPa min
Ultimate Elongation:
500% min | Meet the
requirement |
| ASTM D5151-19 | Water Leak Test for
Detection of Holes | The gloves shall be
free from hole when
tested in accordance
with the method given
in ASTM D5151
AQL=2.5 | Meet the
requirement |
| ASTM D6124-
06(2017) | Residual Powder
Content Test | The powder residue
content shall be not
more than 2mg per
glove. | Meet the
requirement |
| ASTM D3578-19 | Protein Content | $\leq$ 200 ug/dm² | Meet the
requirement |
| ISO 10993-
5:2009 | In vitro Cytotoxicity | Non-cytotoxicity | Failed
Potential toxicity
Grade (3 or 4) |
| ISO 10993-10:
2010 | Skin Sensitization | Non-sensitizing | Meet the
requirement |
| ISO 10993-10:
2010 | Skin irritation | Non-irritating | Meet the
requirement |
| ISO 10993-11:
2017 | Systemic toxicity | Non-systemic toxicity | Meet the
requirement |
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# VIII. Clinical Testing
No clinical study is included in this submission.
### IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Single-use medical latex examination gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K214017.
---
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