K050360 · Shanghai Latex Factory · HIS · Mar 1, 2005 · Obstetrics/Gynecology
Device Facts
Record ID
K050360
Device Name
TULIP CONDOM
Applicant
Shanghai Latex Factory
Product Code
HIS · Obstetrics/Gynecology
Decision Date
Mar 1, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.5300
Device Class
Class 2
Attributes
3rd-Party Reviewed
Indications for Use
The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B, and syohilis. In addition, this condom will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
Device Story
Tulip Condom is a natural rubber latex sheath designed to cover the penis. Features include straight-walled geometry, reservoir tip, 180mm length, 52mm width, and 0.05mm thickness. Lubricated with silicone and dressed with cornstarch. Used by individuals for contraception and prevention of sexually transmitted diseases. Device acts as a physical barrier to prevent exchange of bodily fluids during intercourse. Conforms to ASTM D3492 and ISO 4074 standards.
Clinical Evidence
Bench testing only. Device performance verified against ASTM D3492 and ISO 4074 standards, including air burst pressure (2.3 kPa) and air burst volume (38.5 dm³).
Technological Characteristics
Natural rubber latex sheath; straight-walled with reservoir tip; 180mm length, 52mm width, 0.05mm thickness; silicone lubricant; cornstarch dressing. Conforms to ASTM D3492-02 and ISO 4074-1-1996 standards.
Indications for Use
Indicated for contraception and prophylaxis to prevent pregnancy and transmission of sexually transmitted diseases (including HIV/AIDS, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis) in individuals seeking barrier protection.
Regulatory Classification
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
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MAR 1 - 2005
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters appear to be "K050360D". The characters are written in a cursive style, and the image is in black and white.
# SHANGHAI LATEX FACTORY
Abbreviated 510(k) for Male Latex Condoms
#K_
#### 510(k) SUMMARY 川 .
| Submitted By: | Shanghai Latex Factory<br>1700, Huangxing road, Shanghai, China, 200433<br>Telephone: 0086-021-55090975<br>Fax: 0086-021-55061248 | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Mr. Lou Ji | | |
| Date Prepared: | December 20, 2004 | | |
| Proprietary Name: | Tulip Condom | | |
| Common Name: | Latex Male Condom | | |
| Classification Name: | Condom (21 CFR 884.5300) | | |
| Predicate Device: | Latex Condom<br>510(k) #K[994118] | | |
| Description of Device: | This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip, nominal length 180mm, nominal width 52mm, and nominal thickness 0.05mm. It is lubricated with silicon, with cornstarch as a dressing material. The condom is offered in natural latex color and is designed to conform to established American and international voluntary standards including ASTM D3492-02 and ISO 4074-1-1996 | | |
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### Abbreviated 510(k) for Male Latex Condoms
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This lates condom has the same intended use as the predicate Intended Use of the Device: The condom is used for contraception and for condom. prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B, and syohilis. In addition, this condom will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
Technological Characteristics: This condom has the same technological characteristics as the identified predicate condom above. The design İs 1 (1 conformance with ASTM Latex Condom Standard 03492 and that the condom is made of natural rubber latex. Accordingly, when compared to the predicate device, the tulip condom intended to be introduced does not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect safety and effectiveness.
| Feature | Tulip Condom | Predicate Device |
|-------------------------|--------------|------------------|
| Length (mm) | 180 | 180 |
| Width (mm) | 52 | 52 |
| Thickness (mm) | 0.05 | 0.05 |
| Air Burst Pressure(kPa) | 2.3 | 2.4 |
| Air Burst Volume (dm³) | 38.5 | 36 |
| Lubricant System | Silicone | Silicone |
| Reservoir Tip | Yes | Yes |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Latex Factory % Ms. Laura L. Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K050360
MAR 1 - 2005
Trade/Device Name: Tulip Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: February 11, 2005 Received: February 14, 2005
Dear Ms. Danielson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have 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 the cherosate) to regulary ment date of the Medical Device Amendments, or to devices that have been recy 20, 1770, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmod in accordal of a premarket approval application (PMA). You may, therefore, market the do not require 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your . In addition, 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The FDA Inding of substantial organities and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased on the regulation numer If you desire specific advice for your device on our labering regulation in the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, "Nisoration on your responsibilities under the Act from the 807.97). You may obtain other general mannation on your of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## SHANGHAI LATEX FACTORY
Abbreviated 510(k) for Male Latex Condoms
માં આ
INDICATIONS FOR USE STATEMENT VII.
## Indications for Use
K050360 510(k) Number (if known):
Device Name: Tulip Condom __
Indications For Use: The Tulip condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Prescription Use - - - -(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ...
Concurrence of CDRH, Otlice of Device Evaluation (ODE)
David R. Lyson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
No. 1700, Huangxing Road, Shanghai, P.R.China
PAGE 16 / 16
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
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.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
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.
Where do you find a device's intended use without opening the PDF?
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.
How do you verify an AI chat answer on the device detail page?
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.
6. Collections
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.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
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.
8. Chart view
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.
