K102713 · Tiger Medical Products, Ltd. · FXX · Jan 25, 2011 · General, Plastic Surgery
Device Facts
Record ID
K102713
Device Name
TIGER FLAT SURGICAL MASK
Applicant
Tiger Medical Products, Ltd.
Product Code
FXX · General, Plastic Surgery
Decision Date
Jan 25, 2011
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
The Tiger SFM0001 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Device Story
Tiger Surgical Mask SFM0001 is a 3-ply flat pleated mask; constructed of outer and inner layers of spunbonded polypropylene sandwiching a meltblown polypropylene filter; features urethane elastic ear-loops and an aluminum nose piece with PP covering. Device is non-sterile and intended for single use. Used by operating room personnel and healthcare workers in clinical settings to provide a barrier against microorganisms, body fluids, and particulates. Output is a physical barrier; healthcare providers wear the mask to reduce cross-contamination risk between patients and staff.
Clinical Evidence
No clinical data. Bench testing only. Performance metrics: Fluid resistance (31/32 pass at 120mmHg), Particulate Filtration Efficiency (>99.9% at 2.7µm), Bacterial Filtration Efficiency (99.86%), Flammability (Class 1), Delta-P (3.78). Biocompatibility testing (ISO 10993) showed no cytotoxicity, negligible sensitization, and no irritation.
Indicated for operating room personnel and healthcare workers to protect patients and staff from transfer of microorganisms, blood, body fluids, and airborne particulates.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
Tucker & Associates company-K022256 Surgical face masks
Prestige Ameritech-K061716 Prestige Ameritech Face Mask
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for Tiger Medical Group. The logo consists of a circular emblem on the left and the text "Tiger Medical" on the right. Below "Tiger Medical" is the word "Group" in a smaller font size. The emblem appears to be a stylized image, possibly representing a tiger or a medical symbol.
Page 1 of 2
# 510(k) Summary
JAN 2 5 2011
This summary of 510K safety and effectiveness information is being submitted in accrodance with the requirements of 21 CFR 807.92.
The assigned 510K number is
1. Submitter's Identification:
Tiger Medical Products Ltd
Liulin Tower, STE 1910
1 Huai Hai Zhong Road
Shanghai 200021
P.R.China
Contact:
Maggie Zhong
Tel:+86-21-33907930
Fax:+86-21-33907932
Mail: maggie-zhong2001@vip.sina.com
Date of Summary: March 8th, 2010
- 2. Device Name:
Tiger Surgical Mask
- 3. Classification Name: Surgical Mask
- 4.. Device Description
The Tiger surgical mask SFM0001 (colors: blue) is flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown polypropylene filter material; Ear-loops are made of urethane elastic fiber for free elastic loops. The nose piece is white aluminum strip with PP covering. All of the materials used in the construction of the Tiger flat surgical Masks are being used in currently marketed devices (see predicate information). All items are nosterilize and only for single use.
### 5. Intended Use:
Tiger surgical mask SFM0001 is intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. These would include use procedure mask, isolation mask or dental
### 6. Comparison to Predicate Devices
Tiger surgical mask SFM0001(color: blue) substantially equivalent is safety and effectiveness to the predicate devices.
Tucker & Associates company-K022256 Surgical face masks white, yellow, pink, blue and green
Prestige Ameritech-K061716 Prestige Ameritech Face Mask (multiple labels)
{1}------------------------------------------------
K102713
Image /page/1/Picture/1 description: The image shows the logo for Tiger Medical Group. The logo consists of a circular emblem on the left and the text "Tiger Medical" on the right. Below "Tiger Medical" is the word "Group". The emblem appears to contain the letters TMG.
#### Page 2 of 2
| Performance Characteristics | Test method | Acceptance criteria/result | Predicate<br>results | Predicate device | Predicate device results |
|-----------------------------------------|-------------|---------------------------------------------|----------------------|------------------|--------------------------|
| | | Tiger surgical mask<br>SFM0001 | K061716 | | K022256 |
| Fluid resistance | ASTM 1862 | 31 of 32 Pass at 120mmHg | 29 of 32 pass | | No visual penetration |
| Particulate<br>Filtration<br>Efficiency | ASTM F2299 | >99.9% at 2.7µm | 2.0 microns | | 98.5% at 0.1 microns |
| Bacterial Filtration Efficiency | ASTM F2101 | 99.86% | 99.6% | | 97.9% |
| Flammability Class | 16CFR 1610 | 1 | 1 | | 2 |
| Delta-P | Mil M36954C | 3.78 | 2.6 | | 1.8 |
| Biocompatibility | ISO10993-1 | Cytotoxictiy: no cyctotoxitial<br>potential | N/A | | N/A |
| | | Sensitization: negligible | N/A | | N/A |
| | | Irritation: No reactions | N/A | | N/A |
Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence are as follows:
NELSON Fluid Resistance-Resistance of Liquid (Synthetic Blood Penetration I. Resistance) ASTM F 1862
NELSON Bacterial Filtration Efficiency (BFE) test ASTMF2101 II.
NELSON Particulate Filtration Efficiency (Latex Particule Challenge ASTM F2299) III.
NELSON Flammability, Complied with 16 CFR 1610 Class L IV.
V. TOXIKION Biocompatibility per ISO 10993
It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard.
Discussion of Clinical Tests Performed.
Not Applicable
7. Conclusions
Tiger surgical mask SFM0001 has the same intended use and technology characteristics as the predicate devices (K022256,K061716). Moreover, the bench testing contained in this submission supplied demonstrate that the technological characteristics do not raise any new question of safety or effectiveness. Therefore, the Tiger SFM0001 flat surgical mask is substantially equivalent to the predicate devices.
Confidential - Property of Tiger Medical Group - Not To Be Used Without Written Authorization by Tiger Medical Group
{2}------------------------------------------------
## Standards & Regulations Declaration of Conformity
| As manufacturer | Tiger Medical Products Ltd |
|-----------------|----------------------------|
| | Liulin Tower, STE 1910 |
| | 1 Huai Hai Zhong Road |
| | Shanghai 200021 |
| | P.R.China |
We declare that SFM0001 flat surgical masks are conforms to standards/ regulations listed herein according to FDA requirements.
Standards & regulations declaration of conformity
| Reference | Description | Test Laboratories | Comments |
|---------------|-----------------------------------------------------|---------------------|----------------------|
| ASTM F1862 | Synthetic Blood Penetration<br>Resistance | Nelson Laboratories | Refer to test report |
| ASTM F2101-01 | Bacterial Filtration<br>Efficiency(BFE) and Delta-P | Nelson Laboratories | Refer to test report |
| ASTM F2299 | Particulate Filtration Efficiency | Nelson Laboratories | Refer to test report |
| 16 CFR 1610 | Flammability 16 | Nelson Laboratories | Refer to test report |
| ISO10993-5 | Cytotoxicity | Toxikon Corporation | Refer to test report |
| ISO10993-10 | Irritation & Sensitization | Toxikon Corporation | Refer to test report |
(Signature)
Elaine M. Young
(Typed Name) Elaine M Fong
(Date) March 8, 2010 503
{3}------------------------------------------------
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Ms. Maggie Zhong Consultant Tiger Medical Products, Limited Liulin Tower, STE 1910 1 Huai Hai Zhong Road Shanghai 200021 P.R. China
JAN 2 5 2011
Re: K102713
Trade/Device Name: Tiger Surgical Mask for single use Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: December 23, 2010 Received: January 10, 2011
Dear Ms. Zhong:
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. 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. Bearing of the country of the county of the county of 11.11
{4}------------------------------------------------
### Page 2- Ms. Zhong
Enclosure
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the . MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
{5}------------------------------------------------
### INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): K 1027 / 3
APPLICANT: Tiger Medical Products Ltd
DEVICE NAME: Tiger Surgical Mask for single use
INDICATION FOR USE:
The Tiger SFM0001 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Elizabeth F. Camine-Willee
(Division Sign-Off)
al Profon Olgh-Olf)
Division of Anesthesiology, General Hospital and Control of AneSthesiology, General Devices
510(k) Number: K102713
4
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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
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Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
